Device manufacturer, as written on reports
Ipg Mfg Switzerland: medical device reports filed with FDA
18,336 reports name it as the manufacturer of the device involved, 2011–2019.
- 18,336
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 42.6%
- classified as malfunction
- 62.3% across all reports
- 2%
- classified as death, as reported
- 0.9% across all reports
18,336 medical device reports received by FDA give Ipg Mfg Switzerland as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2011 to January 2019. 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 (55.4%), malfunction (42.6%) and death (2%). 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 |
|---|---|---|---|---|
| Reveal LINQ | Detector and alarm, arrhythmia | 4,766 | 264 | 0% |
| Protecta Xt Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 661 | 3 | 4.5% |
| Activa | Stimulator, electrical, implanted, for parkinsonian tremor | 530 | 1,112 | 0.6% |
| Enrhythm Mri | Pulse generator, permanent, implantable | 399 | 0 | 1% |
| Consulta Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 371 | 0 | 5.9% |
| Viva Quad Xt | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 315 | 0 | 3.8% |
| Protecta Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 308 | 0 | 2.7% |
| Consulta Crt-P | Pulse generator, permanent, implantable | 307 | 5 | 4.7% |
| Primeadvanced | Stimulator, spinal-cord, totally implanted for pain relief | 258 | 16 | 0% |
| Virtuoso Vr | Implantable cardioverter defibrillator (non-crt) | 251 | 0 | 4.7% |
| Viva Xt | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 178 | 0 | 4.6% |
| Syncra CRT-P | Pulse generator, permanent, implantable | 164 | 7 | 4.8% |
| Reveal Xt | Detector and alarm, arrhythmia | 129 | 0 | 0.1% |
| Interstim | Stimulator, electrical, implantable, for incontinence | 127 | 1,522 | 0.2% |
| Kinetra | Stimulator, electrical, implanted, for parkinsonian tremor | 106 | 1 | 2.1% |
| Protecta XT VR | Implantable cardioverter defibrillator (non-crt) | 90 | 8 | 5.3% |
| Insync Sentry | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 87 | 0 | 7% |
| Concerto | Implant, cochlear | 78 | 199 | 2.7% |
| Insync Maximo | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 65 | 0 | 8.9% |
| Enrhythm | Pulse generator, permanent, implantable | 61 | 0 | 9.9% |
| Soletra | Stimulator, electrical, implanted, for parkinsonian tremor | 60 | 12 | 4.2% |
| Reveal Dx | Detector and alarm, arrhythmia | 40 | 0 | 0.4% |
| Azure | Pulse generator, permanent, implantable | 37 | 0 | 1.8% |
| Evera Xt Vr | Implantable cardioverter defibrillator (non-crt) | 37 | 91 | 4.1% |
| Maximo Vr | Implantable cardioverter defibrillator (non-crt) | 36 | 0 | 8.1% |
| Itrel 3 | Stimulator, spinal-cord, totally implanted for pain relief | 35 | 10 | 1.4% |
| Insync | Implantable pacemaker pulse-generator | 29 | 0 | 15.3% |
| Entrust | Implantable cardioverter defibrillator (non-crt) | 22 | 0 | 1.8% |
| Synergy | Coronary drug-eluting stent | 17 | 84 | 3.5% |
| Relia S | Pulse generator, permanent, implantable | 14 | 0 | 3.2% |
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 |
|---|---|---|---|
| DSI | Detector and alarm, arrhythmia | 5,027 | 27.4% |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 3,327 | 18.1% |
| NVZ | Pulse generator, permanent, implantable | 3,083 | 16.8% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 2,778 | 15.2% |
| LWP | Implantable pulse generator, pacemaker (non-crt) | 1,981 | 10.8% |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | 737 | 4% |
| DXY | Implantable pacemaker pulse-generator | 621 | 3.4% |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | 480 | 2.6% |
| EZW | Stimulator, electrical, implantable, for incontinence | 165 | 0.9% |
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) | 46 | 0.3% |
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 Ipg Mfg Switzerland reports
How many FDA device reports name Ipg Mfg Switzerland as manufacturer?
18,336 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Reveal LINQ (4,766), Protecta Xt Crt-D (661), Activa (530), Enrhythm Mri (399) and Consulta Crt-D (371).
Which device types does it report on?
detector and alarm, arrhythmia (27.4%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (18.1%), pulse generator, permanent, implantable (16.8%) and implantable cardioverter defibrillator (non-crt) (15.2%).
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.