Devices › Pulse generator, permanent, implantable
Device brand name · Implantable pulse generator
Insignia: medical device reports filed with FDA
3,792 reports name it, 2002–2024. Manufacturer given most often on reports: Guidant Crm Clonmel Ireland. Product code NVZ.
- 3,792
- device reports naming the brand
- 0% of all MAUDE reports · about 160 a year
- 0
- reports, 12 months to August 2026
- 1 in the 12 months before
- 43.9%
- classified as malfunction
- 43.5% across the product code
- 1.3%
- classified as death, as reported
- 48 reports · not verified by FDA
FDA's MAUDE database holds 3,792 reports that name the brand "Insignia" (implantable pulse generator), received between November 2002 and November 2024; the manufacturer given most often on reports is Guidant Crm Clonmel Ireland. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 1 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 (54.8%), malfunction (43.9%) and death (1.3%); across all pulse generator, permanent, implantable reports (product code NVZ) death is recorded in 4.1% and malfunction in 43.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature discharge of battery (24%), device operates differently than expected (21.6%) and pacing problem (13.1%). The patient problems coded most often are syncope, other (for use when an appropriate patient code cannot be identified) and complaint, ill-defined. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 95,612 reports carrying product code NVZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Premature discharge of battery | 910 | 24% | 11.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 819 | 21.6% | 1.3% |
| Pacing problem | 496 | 13.1% | 10.5% |
| Failure to capture | 432 | 11.4% | 3.4% |
| Over-sensing | 347 | 9.2% | 5.6% |
| Insufficient device problem information | 339 | 8.9% | 1.8% |
| Device sensing problem | 319 | 8.4% | 1.4% |
| High impedance | 295 | 7.8% | 1.7% |
| Connection problema connection problem | 287 | 7.6% | 1.1% |
| Protective measures problem | 150 | 4% | 0.3% |
| Low impedance | 146 | 3.9% | 0.7% |
| Material integrity problema problem with the device material | 143 | 3.8% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 139 | 3.7% | 1.5% |
| Ambient noise problem | 92 | 2.4% | 0.2% |
| Impedance problem | 92 | 2.4% | 0.5% |
| Under-sensing | 66 | 1.7% | 1.4% |
| Battery problema problem with the battery | 63 | 1.7% | 4.7% |
| Electrical /electronic property probleman electrical or electronic problem | 54 | 1.4% | 0.5% |
| Capturing problem | 50 | 1.3% | 0.6% |
| Pacing inadequately | 22 | 0.6% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Syncopefainting | 324 | 8.5% |
| Other (for use when an appropriate patient code cannot be identified) | 150 | 4% |
| Complaint, ill-defined | 118 | 3.1% |
| Cardiac arrestthe heart stopped | 80 | 2.1% |
| Atrial fibrillationan irregular heart rhythm | 59 | 1.6% |
| Deaththe patient died; cause not stated by this term | 52 | 1.4% |
| Pocket erosion | 52 | 1.4% |
| Surgical procedure, repeated | 51 | 1.3% |
| Dizzinesslight-headedness or unsteadiness | 49 | 1.3% |
| Falla fall | 36 | 0.9% |
| Bradycardiaslow heart rate | 28 | 0.7% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 21 | 0.6% |
| Asystole | 14 | 0.4% |
| Sepsisa severe body-wide response to infection | 13 | 0.3% |
| Erosion | 8 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Insignia | Product code NVZ | All MAUDE reports |
|---|---|---|---|
| Reports | 3,792 | 95,612 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 13 | 41 | 9 |
| Classified as injury | 54.8% | 52.1% | 36.2% |
| Classified as malfunction | 43.9% | 43.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.7% | 94.9% |
Shares are of reports, not 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."
Other brands with product code NVZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Adapta | 4,893 | 279 | 7.4% |
| Advisa MRI SureScan | 3,589 | 272 | 1.9% |
| Reply | 2,814 | 9 | 1.5% |
| Altrua | 4,122 | 0 | 2.4% |
| Carelink | 15,005 | 18 | 0% |
| Sensia IPG | 1,391 | 73 | 2.7% |
| Dextrus 4136 | 5,698 | 0 | 0.8% |
| Azure | 919 | 0 | 1.8% |
| MyCareLink Patient Monitor | 893 | 47 | 0.1% |
| Pulse Generator Permanent Implantable | 852 | 24 | 1.1% |
| Fortify Vr U1 6 Sj4 Us | 1,564 | 8 | 1.2% |
| Ellipse VR | 1,507 | 45 | 3.7% |
| Symphony | 1,163 | 133 | 1.6% |
| Fortify Assura VR ICD, US | 4,888 | 213 | 2.3% |
| Consulta Crt-P | 680 | 5 | 4.7% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Insignia reports
How many FDA reports name Insignia?
3,792 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (54.8%), malfunction (43.9%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (24%), device operates differently than expected (21.6%), pacing problem (13.1%), failure to capture (11.4%) and over-sensing (9.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Insignia was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.