Medtronic Puerto Rico Operations medical device reports that give this manufacturer
- Name type
- Device manufacturer, as written on reports
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From February 2004 to September 2026, FDA received 2,013,379 medical device reports that give Medtronic Puerto Rico Operations as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.
FDA received 167,119 reports in the 12 months to September 2026 and 176,688 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 167,119 (4.9%) give Medtronic Puerto Rico Operations as the manufacturer. Manufacturer reports were 100% of the reports that name this manufacturer and 94.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate.
Why manufacturers report
FDA says:
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names
The table has the 109 brand pages with 5 or more reports that give this manufacturer. 123 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Brand name | Product code | Reports | Reports, 12 months to September 2026 |
|---|---|---|---|
| 10-pack RESERVOIR MMT-342 10PK EXTENDED | Pump, infusion | 464 | 647 |
| 530g Insulin Pump | Automated insulin dosing , threshold suspend | 56,026 | 0 |
| 530G Insulin Pump MMT-551NAS | Automated insulin dosing , threshold suspend | 3,545 | 7 |
| 530G Insulin Pump MMT-751LNAS | Automated insulin dosing , threshold suspend | 7,220 | 25 |
| 530g Insulin Pump Mmt-751nab | Automated insulin dosing , threshold suspend | 3,075 | 5 |
| 530g Insulin Pump Mmt-751nal | Automated insulin dosing , threshold suspend | 4,380 | 1 |
| 530g Insulin Pump Mmt-751nap | Automated insulin dosing , threshold suspend | 2,872 | 2 |
| 530g Insulin Pump Mmt-751nas | Automated insulin dosing , threshold suspend | 10,707 | 24 |
| 630g Insulin Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 3,577 | 0 |
| 630g Insulin Pump 630g Black Mg | Pump, infusion, insulin, to be used with invasive glucose sensor | 218 | 0 |
| 630G Insulin PUMP MMT-1715K 630G BLACK MG | Automated insulin dosing , threshold suspend | 86,006 | 495 |
| 630G Insulin PUMP MMT-1715KL 630G | Automated insulin dosing , threshold suspend | 34,727 | 794 |
| 630G Insulin PUMP MMT-1715KR 630G | Automated insulin dosing , threshold suspend | 3,268 | 149 |
| 640g | Pump, infusion, insulin, to be used with invasive glucose sensor | 120 | 0 |
| 640g Insulin Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 16,605 | 0 |
| 640g Insulin Pump Mmt-1711b | Pump, infusion, insulin, to be used with invasive glucose sensor | 3,390 | 0 |
| 640G Insulin Pump MMT-1711K | Pump, infusion, insulin, to be used with invasive glucose sensor | 76,235 | 126 |
| 640g Insulin Pump Mmt-1711p | Pump, infusion, insulin, to be used with invasive glucose sensor | 902 | 0 |
| 640g Insulin Pump Mmt-1711w | Pump, infusion, insulin, to be used with invasive glucose sensor | 1,913 | 2 |
| 640g Insulin Pump Mmt-1712b | Pump, infusion, insulin, to be used with invasive glucose sensor | 4,838 | 1 |
| 640G Insulin Pump MMT-1712K | Pump, infusion, insulin, to be used with invasive glucose sensor | 119,580 | 1,418 |
| 640g Insulin Pump Mmt-1712p 640g 3ml Purple Mg | Pump, infusion, insulin, to be used with invasive glucose sensor | 977 | 0 |
| 640g Insulin Pump Mmt-1712w | Pump, infusion, insulin, to be used with invasive glucose sensor | 3,188 | 1 |
| 670G Insulin Pump MMT-1780KL | Automated insulin dosing device system, single hormonal control | 77,843 | 931 |
| Activa | Stimulator, electrical, implanted, for parkinsonian tremor | 16,061 | 1,035 |
| Activa Pc | Stimulator, electrical, implanted, for parkinsonian tremor | 10 | 0 |
| Capsurefix Novus | Permanent pacemaker electrode | 24 | 3 |
| Dbs | Stimulator, electrical, implanted, for parkinsonian tremor | 85 | 0 |
| Deep Brain Stimulation Lead | Stimulator, electrical, implanted, for parkinsonian tremor | 126 | 0 |
| Enterra | Intestinal stimulator | 427 | 0 |
| Evera XT VR | Implantable cardioverter defibrillator (non-crt) | 214 | 88 |
| Inceptiv | Stimulator, spinal-cord, totally implanted for pain relief | 2,391 | 1,633 |
| Insulin Infusion Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 7 | 0 |
| Insulin Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 110 | 1 |
| Intellis | Stimulator, spinal-cord, totally implanted for pain relief | 39,692 | 4,521 |
| Interstim | Stimulator, electrical, implantable, for incontinence | 2,668 | 1,526 |
| InterStim X | Stimulator, electrical, implantable, for incontinence | 8,658 | 3,027 |
| Itrel 3 | Stimulator, spinal-cord, totally implanted for pain relief | 239 | 9 |
| Kinetra | Stimulator, electrical, implanted, for parkinsonian tremor | 278 | 1 |
| MiniMed 720G OUS BLE Connect 3.0 mgdl | Pump, infusion, insulin, to be used with invasive glucose sensor | 3,290 | 1,288 |
| MiniMed 720G OUS BLE Connect 3.0 mmol/L | Pump, infusion, insulin, to be used with invasive glucose sensor | 414 | 505 |
| MiniMed 740G OUS System BLE Connect 3.0 mg/dL | Pump, infusion, insulin, to be used with invasive glucose sensor | 4,638 | 1,561 |
| MiniMed 740G OUS System BLE Connect 3.0 mmol/L | Pump, infusion, insulin, to be used with invasive glucose sensor | 22 | 427 |
| MiniMed 770G OUS System BLE Connect 3.0 mg/dL | Automated insulin dosing device system, single hormonal control | 2,376 | 529 |
| MiniMed 770G OUS System BLE Connect 3.0 mmol/L | Automated insulin dosing device system, single hormonal control | 6,624 | 434 |
| MiniMed 770G US System BLE Connect 3.0 mg/dL | Automated insulin dosing device system, single hormonal control | 84,721 | 4,171 |
| MiniMed 780G OUS System BLE Connect 3.0 mg/dL | Automated insulin dosing device system, single hormonal control | 13,769 | 280 |
| MiniMed 780G OUS System BLE Connect 3.0 mmol/L | Automated insulin dosing device system, single hormonal control | 67,373 | 17,567 |
| MiniMed 780G US System BLE Connect 3.0 mg/dL | Automated insulin dosing device system, single hormonal control | 114,527 | 52,415 |
| MMT-712 PARADIGM Insulin Pump | Pump, infusion, insulin | 25,241 | 3,815 |
| MMT-715 PARADIGM Insulin Pump | Pump, infusion, insulin | 2,000 | 119 |
| Model Not Specified | Pump, infusion, insulin | 28 | 0 |
| Paradigm Insulin Infusion Pump | Pump, infusion, insulin | 9,866 | 0 |
| Paradigm Real-Time Insulin Infusion Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 74,820 | 0 |
| Paradigm Real-Time Insulin Infusion Pump Mmt-722nas | Pump, infusion, insulin, to be used with invasive glucose sensor | 7 | 6 |
| Paradigm REAL-Time Insulin Infusion Pump MMT-722WWS | Pump, infusion, insulin, to be used with invasive glucose sensor | 17 | 225 |
| Paradigm REAL-Time Insulin Infusion Pump MMT-754WWS | Pump, infusion, insulin, to be used with invasive glucose sensor | 9,567 | 547 |
| Paradigm Real-Time Revel Insulin Infusion Pump | Pump, infusion, insulin, to be used with invasive glucose sensor | 114,911 | 0 |
| Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNAS | Pump, infusion, insulin, to be used with invasive glucose sensor | 10,952 | 28 |
| Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723NAB | Pump, infusion, insulin, to be used with invasive glucose sensor | 820 | 7 |
| Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nas | Pump, infusion, insulin, to be used with invasive glucose sensor | 7,011 | 44 |
| Percept | Stimulator, electrical, implanted, for parkinsonian tremor | 1,854 | 1,238 |
| Primeadvanced | Stimulator, spinal-cord, totally implanted for pain relief | 106 | 12 |
| Prostiva | Unit, electrosurgical, endoscopic (with or without accessories) | 27 | 0 |
| Pump 1886 780G OUS BLE Pump mg/dL | Automated insulin dosing device system, single hormonal control | 85,690 | 34,249 |
| Pump Mmt-1711kl 640g V4 10 Bk Sf Mm | Pump, infusion, insulin, to be used with invasive glucose sensor | 10,022 | 146 |
| Pump Mmt-1712kl 640g V4 10 Bk Sf Mg | Pump, infusion, insulin, to be used with invasive glucose sensor | 21,513 | 787 |
| Pump Mmt-1714k 630g Black Mmol Canada | Automated insulin dosing , threshold suspend | 11,659 | 63 |
| Pump Mmt-1715km 630g 3ml Black Medi | Automated insulin dosing , threshold suspend | 15,234 | 12 |
| Pump Mmt-1780k 670g 3ml Black | Automated insulin dosing device system, single hormonal control | 7,772 | 8 |
| Pump MMT-1780KPK 670G Pathway Black MG | Automated insulin dosing device system, single hormonal control | 224,495 | 739 |
| Pump Mmt-1781k 670g V4 11 Mg | Automated insulin dosing device system, single hormonal control | 16,376 | 512 |
| Pump Mmt-1781kl 670g Mg Rpl | Automated insulin dosing device system, single hormonal control | 3,009 | 34 |
| Pump Mmt-1782k 670g V4 11 Mm | Automated insulin dosing device system, single hormonal control | 23,226 | 108 |
| Pump Mmt-1782kl 670g Mm Rpl | Automated insulin dosing device system, single hormonal control | 4,462 | 37 |
| Pump Mmt-1880l Mm770g Ble Mg | Automated insulin dosing device system, single hormonal control | 24,142 | 2,737 |
| PUMP MMT-1884L MM780G BLE 3.0 mg/ml | Automated insulin dosing device system, single hormonal control | 35,033 | 8,237 |
| Pump Mmt-1885l Mm780g Ble Mmol | Automated insulin dosing device system, single hormonal control | 1,922 | 121 |
| Reservoir | Pump, infusion | 644 | 0 |
| Reservoir 1 8 Ml | Pump, infusion | 423 | 0 |
| Reservoir 1 8ml | Pump, infusion | 6,863 | 0 |
| Reservoir 1.8ML MMT-326A | Pump, infusion | 20 | 171 |
| Reservoir 2pk 3ml | Pump, infusion | 130 | 0 |
| Reservoir 3cc | Pump, infusion | 6 | 0 |
| Reservoir 3ml | Pump, infusion | 13,244 | 0 |
| Reservoir 3ML MMT-332A | Pump, infusion | 19,499 | 1,862 |
| Restore Advanced Rechargeable | Stimulator, spinal-cord, totally implanted for pain relief | 677 | 0 |
| Restore Prime | Stimulator, spinal-cord, totally implanted for pain relief | 49 | 2 |
| Restore Prime Advanced | Stimulator, spinal-cord, totally implanted for pain relief | 348 | 0 |
| Restore Rechargable Neurostimulator | Stimulator, spinal-cord, totally implanted for pain relief | 460 | 0 |
| Restore Rechargeable Neurostimulator | Stimulator, spinal-cord, totally implanted for pain relief | 406 | 0 |
| Restore Sensor | Stimulator, spinal-cord, totally implanted for pain relief | 644 | 34 |
| Restore Sensor Mri | Stimulator, spinal-cord, totally implanted for pain relief | 115 | 0 |
| Restore Ultra | Stimulator, spinal-cord, totally implanted for pain relief | 667 | 35 |
| Restoresensor Mri | Stimulator, spinal-cord, totally implanted for pain relief | 96 | 0 |
| Sensor Enlite | Automated insulin dosing , threshold suspend | 52 | 0 |
| Sensor Enlite Mmt-7008a | Automated insulin dosing , threshold suspend | 2,032 | 4 |
| Sensor Mmt-7020a Enlite3 5pk Us | Automated insulin dosing device system, single hormonal control | 848 | 120 |
| Sensor Mmt-7040a Guardian4 5pk Us | Automated insulin dosing device system, single hormonal control | 3,825 | 1,994 |
| Sensor Mmt-7040c1 Guardian4 5pk Ous 1 | Automated insulin dosing device system, single hormonal control | 905 | 1,600 |
| Soletra | Stimulator, electrical, implanted, for parkinsonian tremor | 821 | 11 |
| Specify | Stimulator, spinal-cord, totally implanted for pain relief | 8 | 0 |
| SureScan | Stimulator, spinal-cord, totally implanted for pain relief | 27,423 | 452 |
| Synergy | Coronary drug-eluting stent | 569 | 77 |
| Unknown NGP | Automated insulin dosing device system, single hormonal control | 2,827 | 3,940 |
| Viva Quad S | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 103 | 0 |
| Viva Quad Xt | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 417 | 0 |
| Viva S | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 42 | 0 |
| Viva Xt | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 524 | 0 |
Device types
The table has the 22 device types with 5 or more reports that give this manufacturer. The rows are in order of name.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 5,839 | 0.3% | |
| Injury | 398,206 | 19.8% | |
| Malfunction | 1,609,062 | 79.9% | |
| Other | 76 | under 0.1% | |
| Not given | 196 | under 0.1% |
The event type is the classification that the reporter gave. FDA does not verify it.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Medtronic Puerto Rico Operations: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/medtronic-puerto-rico-operations/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Does a large count say something about the manufacturer?
Not by itself. FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (5,839), injury (398,206), malfunction (1,609,062) and other (76). The event type is the classification that the reporter gave. FDA does not verify it.
Why can one company have more than one page?
The manufacturer field is free text on the report. This page counts the 2,013,379 reports with the name Medtronic Puerto Rico Operations after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.