Device manufacturer, as written on reports

Medtronic Puerto Rico Operations: medical device reports filed with FDA

2,007,381 reports name it as the manufacturer of the device involved, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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." And: "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."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,007,381
reports naming it as manufacturer: 7.7% of all MAUDE reports; 183,158
reports, 12 months to August 2026: 169,690 in the 12 months before; 79.9%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

2,007,381 medical device reports received by FDA give Medtronic Puerto Rico Operations as the manufacturer of the device involved, 7.7% of the MAUDE database, from February 2004 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

183,158 reports arrived in the 12 months to August 2026, close to the 169,690 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (79.9%), injury (19.8%) and death (0.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Pump MMT-1780KPK 670G Pathway Black MG	Automated insulin dosing device system, single hormonal control	224,469	835	0.2%
640G Insulin Pump MMT-1712K	Pump, infusion, insulin, to be used with invasive glucose sensor	119,540	1,598	0.1%
Paradigm Real-Time Revel Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	114,911	0	0.6%
MiniMed 780G US System BLE Connect 3.0 mg/dL	Automated insulin dosing device system, single hormonal control	112,810	57,140	0.1%
630G Insulin PUMP MMT-1715K 630G BLACK MG	Automated insulin dosing , threshold suspend	86,006	583	0.4%
MiniMed 770G US System BLE Connect 3.0 mg/dL	Automated insulin dosing device system, single hormonal control	84,584	4,838	0.2%
Pump 1886 780G OUS BLE Pump mg/dL	Automated insulin dosing device system, single hormonal control	84,255	36,883	0%
670G Insulin Pump MMT-1780KL	Automated insulin dosing device system, single hormonal control	77,820	1,121	0.2%
640G Insulin Pump MMT-1711K	Pump, infusion, insulin, to be used with invasive glucose sensor	76,235	151	0.1%
Paradigm Real-Time Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	74,820	0	0.3%
MiniMed 780G OUS System BLE Connect 3.0 mmol/L	Automated insulin dosing device system, single hormonal control	66,658	19,194	0%
530g Insulin Pump	Automated insulin dosing , threshold suspend	56,026	0	0.8%
Intellis	Stimulator, spinal-cord, totally implanted for pain relief	39,511	4,743	0%
PUMP MMT-1884L MM780G BLE 3.0 mg/ml	Automated insulin dosing device system, single hormonal control	34,845	9,703	0.1%
630G Insulin PUMP MMT-1715KL 630G	Automated insulin dosing , threshold suspend	34,710	945	0.5%
SureScan	Stimulator, spinal-cord, totally implanted for pain relief	27,423	490	0%
MMT-712 PARADIGM Insulin Pump	Pump, infusion, insulin	25,113	4,138	0%
Pump Mmt-1880l Mm770g Ble Mg	Automated insulin dosing device system, single hormonal control	24,043	3,148	0.2%
Pump Mmt-1782k 670g V4 11 Mm	Automated insulin dosing device system, single hormonal control	23,226	137	0.1%
Pump Mmt-1712kl 640g V4 10 Bk Sf Mg	Pump, infusion, insulin, to be used with invasive glucose sensor	21,513	952	0%
Reservoir 3ML MMT-332A	Pump, infusion	19,424	2,008	0.4%
640g Insulin Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	16,605	0	0%
Pump Mmt-1781k 670g V4 11 Mg	Automated insulin dosing device system, single hormonal control	16,376	617	0%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	16,032	1,112	0.6%
Pump Mmt-1715km 630g 3ml Black Medi	Automated insulin dosing , threshold suspend	15,234	18	0.8%
MiniMed 780G OUS System BLE Connect 3.0 mg/dL	Automated insulin dosing device system, single hormonal control	13,769	340	0%
Reservoir 3ml	Pump, infusion	13,244	0	0.8%
Pump Mmt-1714k 630g Black Mmol Canada	Automated insulin dosing , threshold suspend	11,659	73	0.2%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNAS	Pump, infusion, insulin, to be used with invasive glucose sensor	10,952	41	0.8%
530g Insulin Pump Mmt-751nas	Automated insulin dosing , threshold suspend	10,707	32	0.6%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
OZP	Automated insulin dosing device system, single hormonal control	810,160	40.4%
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	598,106	29.8%
OZO	Automated insulin dosing , threshold suspend	264,230	13.2%
LGW	Stimulator, spinal-cord, totally implanted for pain relief	78,336	3.9%
FRN	Pump, infusion	47,402	2.4%
LKK	Pump, infusion, implanted, programmable	47,223	2.4%
EZW	Stimulator, electrical, implantable, for incontinence	44,212	2.2%
LZG	Pump, infusion, insulin	37,020	1.8%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	15,164	0.8%
QFG	Alternate controller enabled insulin infusion pump	12,398	0.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.3%5,833

Injury19.8%397,376

Malfunction79.9%1,603,901

Other0%75

Not given0%196

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medtronic Puerto Rico Operations reports

How many FDA device reports name Medtronic Puerto Rico Operations as manufacturer?

2,007,381 reports through August 2026, 183,158 of them in the latest 12 months.

Which of its brands appear most often?

Pump MMT-1780KPK 670G Pathway Black MG (224,469), 640G Insulin Pump MMT-1712K (119,540), Paradigm Real-Time Revel Insulin Infusion Pump (114,911), MiniMed 780G US System BLE Connect 3.0 mg/dL (112,810) and 630G Insulin PUMP MMT-1715K 630G BLACK MG (86,006).

Which device types does it report on?

automated insulin dosing device system, single hormonal control (40.4%), pump, infusion, insulin, to be used with invasive glucose sensor (29.8%), automated insulin dosing , threshold suspend (13.2%) and stimulator, spinal-cord, totally implanted for pain relief (3.9%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.