Devices › Implantable pacemaker pulse-generator
Device brand name · Implantable pulse generator
Insignia Ultra: medical device reports filed with FDA
797 reports name it, 2004–2008. Manufacturer given most often on reports: Cardiac Pacemakers. Product code DXY.
- 797
- device reports naming the brand
- 0% of all MAUDE reports · about 36 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 29.9%
- classified as malfunction
- 41.2% across the product code
- 5.4%
- classified as death, as reported
- 43 reports · not verified by FDA
797 medical device reports received by FDA name the brand "Insignia Ultra" (implantable pulse generator); the manufacturer given most often on reports is Cardiac Pacemakers; received from February 2004 to November 2008. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (64.7%), malfunction (29.9%) and death (5.4%); across all implantable pacemaker pulse-generator reports (product code DXY) death is recorded in 3.4% and malfunction in 41.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are pacing problem (23.8%), failure to capture (22.2%) and malfunction (15.6%). The patient problems coded most often are syncope, other (for use when an appropriate patient code cannot be identified) and death. 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
No report naming Insignia Ultra was received in the five years to August 2026; the latest was received in November 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 57,832 reports carrying product code DXY. 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 |
|---|---|---|---|
| Pacing problem | 190 | 23.8% | 6.4% |
| Failure to capture | 177 | 22.2% | 6.3% |
| Malfunction | 124 | 15.6% | 1.9% |
| Noise | 89 | 11.2% | 1% |
| Low battery | 88 | 11% | 5.3% |
| Over-sensing | 85 | 10.7% | 5.4% |
| Pacing inadequately | 68 | 8.5% | 1.2% |
| High impedance | 63 | 7.9% | 3.8% |
| Loss of threshold | 54 | 6.8% | 0.6% |
| Difficult to interrogate | 52 | 6.5% | 3.1% |
| Sensing intermittently | 37 | 4.6% | 0.7% |
| Failure to deliverthe device did not deliver the dose or item | 35 | 4.4% | 0.2% |
| Normal | 32 | 4% | 2% |
| Telemetry discrepancy | 29 | 3.6% | 2.3% |
| Mechanical problema mechanical problem | 27 | 3.4% | 1.4% |
| Connection error | 25 | 3.1% | 0.7% |
| Under-sensing | 25 | 3.1% | 1.4% |
| False reading from device non-compliance | 21 | 2.6% | 0.2% |
| Performance | 13 | 1.6% | 0.4% |
| Low readingsreadings were too low | 12 | 1.5% | 0.1% |
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 | 128 | 16.1% |
| Other (for use when an appropriate patient code cannot be identified) | 115 | 14.4% |
| Deaththe patient died; cause not stated by this term | 43 | 5.4% |
| Surgical procedure, repeated | 42 | 5.3% |
| Bradycardiaslow heart rate | 21 | 2.6% |
| Asystole | 17 | 2.1% |
| Atrial fibrillationan irregular heart rhythm | 15 | 1.9% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 9 | 1.1% |
| Falla fall | 6 | 0.8% |
| Atrial tachycardia | 3 | 0.4% |
| Cardiopulmonary arrest | 3 | 0.4% |
| Arrhythmia | 2 | 0.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 2 | 0.3% |
| Atrial flutter | 1 | 0.1% |
| Breathing difficulties | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Insignia Ultra | Product code DXY | All MAUDE reports |
|---|---|---|---|
| Reports | 797 | 57,832 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 54 | 34 | 9 |
| Classified as injury | 64.7% | 54.4% | 36.2% |
| Classified as malfunction | 29.9% | 41.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 96.6% | 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 DXY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Tendril Mri | 7,076 | 422 | 4.1% |
| Medtronic Lead | 2,351 | 328 | 9.5% |
| Carelink Program W/Telemetry C | 1,681 | 0 | 0% |
| Carelink | 15,005 | 18 | 0% |
| Assurity Mri | 18,995 | 2,035 | 1.8% |
| Insignia Plus | 940 | 0 | 9.1% |
| Meta Dddr | 532 | 0 | 0.4% |
| Enpulse | 606 | 3 | 10.4% |
| Medtronic ICD | 404 | 105 | 23.8% |
| Insignia Entra | 374 | 0 | 10.2% |
| Anthem Rf | 372 | 0 | 4.3% |
| Tempo | 721 | 155 | 0.7% |
| Medtronic | 2,953 | 17 | 4.4% |
| Symphony | 1,163 | 133 | 1.6% |
| Insignia I Plus Dddro Is-1 | 325 | 0 | 0.9% |
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 Ultra reports
How many FDA reports name Insignia Ultra?
797 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 (64.7%), malfunction (29.9%) and death (5.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pacing problem (23.8%), failure to capture (22.2%), malfunction (15.6%), noise (11.2%) and low battery (11%). 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 Ultra 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.