Devices › Implantable pacemaker pulse-generator
Device brand name · Implantable pulse generator
Enpulse: medical device reports filed with FDA
606 reports name it, 2005–2026. Manufacturer given most often on reports: Medtronic Med Rel. Product code DXY.
- 606
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 3
- reports, 12 months to August 2026
- 1 in the 12 months before
- 28.9%
- classified as malfunction
- 41.2% across the product code
- 10.4%
- classified as death, as reported
- 63 reports · not verified by FDA
FDA's MAUDE database holds 606 reports that name the brand "Enpulse" (implantable pulse generator), received between February 2005 and July 2026; the manufacturer given most often on reports is Medtronic Med Rel. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, up 200% from 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 (60.7%), malfunction (28.9%) and death (10.4%); 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 (10.1%), low battery (9.6%) and premature discharge of battery (9.1%). The patient problems coded most often are death, syncope 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 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 | 61 | 10.1% | 6.4% |
| Low battery | 58 | 9.6% | 5.3% |
| Premature discharge of battery | 55 | 9.1% | 8.4% |
| Device remains activated | 46 | 7.6% | 1.1% |
| Premature elective replacement indicator | 41 | 6.8% | 2.2% |
| Failure to capture | 29 | 4.8% | 6.3% |
| Failure to interrogate | 26 | 4.3% | 6.1% |
| Other (for use when an appropriate device code cannot be identified) | 21 | 3.5% | 4.5% |
| High impedance | 20 | 3.3% | 3.8% |
| Insufficient device problem information | 19 | 3.1% | 0.9% |
| Power problem | 19 | 3.1% | 0.8% |
| Difficult to interrogate | 17 | 2.8% | 3.1% |
| Over-sensing | 17 | 2.8% | 5.4% |
| No device output | 16 | 2.6% | 4.8% |
| High sensing threshold | 14 | 2.3% | 0.6% |
| Battery problema problem with the battery | 13 | 2.1% | 0.5% |
| Defective devicethe device was defective | 11 | 1.8% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 10 | 1.7% | 1.2% |
| Data problem | 10 | 1.7% | 0.4% |
| Incorrect measurementthe device measured wrongly | 10 | 1.7% | 1.4% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 63 | 10.4% |
| Syncopefainting | 20 | 3.3% |
| Complaint, ill-defined | 15 | 2.5% |
| Painpain, site not specified | 15 | 2.5% |
| Dizzinesslight-headedness or unsteadiness | 14 | 2.3% |
| Dyspneashortness of breath | 13 | 2.1% |
| Bradycardiaslow heart rate | 11 | 1.8% |
| Cardiac arrestthe heart stopped | 10 | 1.7% |
| Failure of implant | 10 | 1.7% |
| Muscle stimulation | 10 | 1.7% |
| Endocarditis | 5 | 0.8% |
| Fatiguetiredness | 5 | 0.8% |
| Palpitationsawareness of the heartbeat | 5 | 0.8% |
| Atrial fibrillationan irregular heart rhythm | 4 | 0.7% |
| Fainting | 4 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enpulse | Product code DXY | All MAUDE reports |
|---|---|---|---|
| Reports | 606 | 57,832 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 104 | 34 | 9 |
| Classified as injury | 60.7% | 54.4% | 36.2% |
| Classified as malfunction | 28.9% | 41.2% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| Insignia Ultra | 797 | 0 | 5.4% |
| Meta Dddr | 532 | 0 | 0.4% |
| 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 Enpulse reports
How many FDA reports name Enpulse?
606 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
injury (60.7%), malfunction (28.9%) and death (10.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pacing problem (10.1%), low battery (9.6%), premature discharge of battery (9.1%), device remains activated (7.6%) and premature elective replacement indicator (6.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Enpulse 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.