Device manufacturer, as written on reports
Mdt Puerto Rico Operations: medical device reports filed with FDA
35,572 reports name it as the manufacturer of the device involved, 2007–2026.
- 35,572
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 27
- reports, 12 months to August 2026
- 48 in the 12 months before
- 31.7%
- classified as malfunction
- 62.3% across all reports
- 0.7%
- classified as death, as reported
- 0.9% across all reports
35,572 medical device reports received by FDA give Mdt Puerto Rico Operations as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2007 to July 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
27 reports arrived in the 12 months to August 2026, down 44% from 48 in 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 injury (67.7%), malfunction (31.7%) and death (0.7%). 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 |
|---|---|---|---|---|
| Restore Ultra | Stimulator, spinal-cord, totally implanted for pain relief | 695 | 39 | 0.1% |
| Activa | Stimulator, electrical, implanted, for parkinsonian tremor | 377 | 1,112 | 0.6% |
| Primeadvanced | Stimulator, spinal-cord, totally implanted for pain relief | 276 | 16 | 0% |
| Restore Sensor | Stimulator, spinal-cord, totally implanted for pain relief | 213 | 40 | 0.1% |
| Restore Advanced | Stimulator, spinal-cord, totally implanted for pain relief | 180 | 18 | 0.1% |
| Restore | Stimulator, spinal-cord, totally implanted for pain relief | 178 | 27 | 0.1% |
| Soletra | Stimulator, electrical, implanted, for parkinsonian tremor | 169 | 12 | 4.2% |
| Interstim | Stimulator, electrical, implantable, for incontinence | 144 | 1,522 | 0.2% |
| Synergy | Coronary drug-eluting stent | 113 | 84 | 3.5% |
| Kinetra | Stimulator, electrical, implanted, for parkinsonian tremor | 96 | 1 | 2.1% |
| Enterra | Intestinal stimulator | 84 | 0 | 0.8% |
| Itrel 3 | Stimulator, spinal-cord, totally implanted for pain relief | 49 | 10 | 1.4% |
| Synergy Versitrel | Stimulator, spinal-cord, totally implanted for pain relief | 42 | 4 | 0% |
| Indura | Pump, infusion, implanted, programmable | 31 | 0 | 0.8% |
| Tbd | Catheter and tip, suction | 31 | 8 | 0.6% |
| Restore Prime | Stimulator, spinal-cord, totally implanted for pain relief | 25 | 2 | 1.1% |
| Synchromed El | Pump, infusion, implanted, programmable | 19 | 2 | 4.9% |
| Activa Pc | Stimulator, electrical, implanted, for parkinsonian tremor | 7 | 0 | 1.2% |
| CD HORIZON Spinal System | Appliance, fixation, spinal interlaminal | 7 | 634 | 0.3% |
| Restore Prime Advanced | Stimulator, spinal-cord, totally implanted for pain relief | 7 | 0 | 0.4% |
| Synchromed | Pump, infusion, implanted, programmable | 6 | 3 | 3.2% |
| Xps Blade | Bur, ear, nose and throat | 6 | 71 | 0% |
| Intrathecal Catheter | Pump, infusion, implanted, programmable | 5 | 18 | 0.1% |
| Restore Advanced Rechargeable | Stimulator, spinal-cord, totally implanted for pain relief | 4 | 0 | 0.6% |
| Unknown Implantable Neurostimulator | Stimulator, spinal-cord, totally implanted for pain relief | 4 | 0 | 2.2% |
| Xps Bur | Bur, ear, nose and throat | 4 | 12 | 0% |
| Adapta | Pulse generator, permanent, implantable | 1 | 279 | 7.4% |
| Capsurefix | Permanent pacemaker electrode | 1 | 0 | 6.3% |
| Catheter | Pump, infusion, implanted, programmable | 1 | 9 | 3.7% |
| Cd Horizon | Appliance, fixation, spinal interlaminal | 1 | 38 | 0.3% |
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 |
|---|---|---|---|
| LKK | Pump, infusion, implanted, programmable | 31,812 | 89.4% |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | 1,842 | 5.2% |
| EZW | Stimulator, electrical, implantable, for incontinence | 1,065 | 3% |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | 689 | 1.9% |
| LNQ | Intestinal stimulator | 84 | 0.2% |
| EQJ | Bur, ear, nose and throat | 53 | 0.1% |
| KWP | Appliance, fixation, spinal interlaminal | 9 | 0% |
| MRU | Implanted subcortical electrical stimulator (motor disorders) | 7 | 0% |
| DTB | Permanent pacemaker electrode | 1 | 0% |
| FMF | Syringe, piston | 1 | 0% |
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Mdt Puerto Rico Operations reports
How many FDA device reports name Mdt Puerto Rico Operations as manufacturer?
35,572 reports through August 2026, 27 of them in the latest 12 months.
Which of its brands appear most often?
Restore Ultra (695), Activa (377), Primeadvanced (276), Restore Sensor (213) and Restore Advanced (180).
Which device types does it report on?
pump, infusion, implanted, programmable (89.4%), stimulator, spinal-cord, totally implanted for pain relief (5.2%), stimulator, electrical, implantable, for incontinence (3%) and stimulator, electrical, implanted, for parkinsonian tremor (1.9%).
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.