Device manufacturer, as written on reports
Medtronic Med Rel: medical device reports filed with FDA
31,029 reports name it as the manufacturer of the device involved, 1997–2012.
- 31,029
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 21.9%
- classified as malfunction
- 62.3% across all reports
- 10.9%
- classified as death, as reported
- 0.9% across all reports
31,029 medical device reports received by FDA give Medtronic Med Rel as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1997 to November 2012. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
0 reports arrived in the 12 months to August 2026, and none 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%), malfunction (21.9%) and death (10.9%). 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 |
|---|---|---|---|---|
| Consulta Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,300 | 0 | 5.9% |
| Reveal Xt | Detector and alarm, arrhythmia | 633 | 0 | 0.1% |
| Insync Sentry | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 552 | 0 | 7% |
| Entrust At | Implantable cardioverter defibrillator (non-crt) | 506 | 0 | 7.6% |
| Insync Maximo | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 477 | 0 | 8.9% |
| Consulta | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 461 | 0 | 9.7% |
| Micro Jewel | Implantable cardioverter defibrillator (non-crt) | 440 | 0 | 1.6% |
| Enpulse | Implantable pacemaker pulse-generator | 412 | 3 | 10.4% |
| Reveal Dx | Detector and alarm, arrhythmia | 389 | 0 | 0.4% |
| Virtuoso Vr | Implantable cardioverter defibrillator (non-crt) | 375 | 0 | 4.7% |
| Maximo Vr | Implantable cardioverter defibrillator (non-crt) | 367 | 0 | 8.1% |
| Revo MRI SureScan | Implantable pulse generator, pacemaker (non-crt) | 309 | 12 | 2.9% |
| Intrinsic | Implantable cardioverter defibrillator (non-crt) | 269 | 0 | 8.5% |
| Entrust Vr | Implantable cardioverter defibrillator (non-crt) | 265 | 0 | 5.6% |
| Secura Vr | Implantable cardioverter defibrillator (non-crt) | 223 | 0 | 8.8% |
| Protecta Xt Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 164 | 3 | 4.5% |
| Gem Vr | Implantable cardioverter defibrillator (non-crt) | 115 | 0 | 6.8% |
| Marquis Vr | Implantable cardioverter defibrillator (non-crt) | 58 | 0 | 4.8% |
| Sigma 100 S | Implantable pacemaker pulse-generator | 7 | 0 | 1.8% |
| Sigma 100 Vvi | Implantable pacemaker pulse-generator | 2 | 0 | 1.4% |
| Soletra | Stimulator, electrical, implanted, for parkinsonian tremor | 2 | 12 | 4.2% |
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 |
|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-crt) | 9,332 | 30.1% |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 8,488 | 27.4% |
| DXY | Implantable pacemaker pulse-generator | 7,839 | 25.3% |
| NVZ | Pulse generator, permanent, implantable | 3,989 | 12.9% |
| DSI | Detector and alarm, arrhythmia | 1,023 | 3.3% |
| LWP | Implantable pulse generator, pacemaker (non-crt) | 330 | 1.1% |
| MXC | Recorder, event, implantable cardiac, (without arrhythmia detection) | 14 | 0% |
| DTB | Permanent pacemaker electrode | 6 | 0% |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | 2 | 0% |
| EZW | Stimulator, electrical, implantable, for incontinence | 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 Medtronic Med Rel reports
How many FDA device reports name Medtronic Med Rel as manufacturer?
31,029 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Consulta Crt-D (1,300), Reveal Xt (633), Insync Sentry (552), Entrust At (506) and Insync Maximo (477).
Which device types does it report on?
implantable cardioverter defibrillator (non-crt) (30.1%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (27.4%), implantable pacemaker pulse-generator (25.3%) and pulse generator, permanent, implantable (12.9%).
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.