Devices › Pulse-generator, pacemaker, external
Device brand name · Pulse-generator pacemaker external
Temporary External Pacemaker: medical device reports filed with FDA
363 reports name it, 2019–2026. Manufacturer given most often on reports: Medtronic. Product code DTE.
- 363
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 96
- reports, 12 months to August 2026
- 51 in the 12 months before
- 89%
- classified as malfunction
- 91.1% across the product code
- 0.8%
- classified as death, as reported
- 3 reports · not verified by FDA
363 medical device reports received by FDA name the brand "Temporary External Pacemaker" (pulse-generator pacemaker external); the manufacturer given most often on reports is Medtronic; received from April 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
96 reports arrived in the 12 months to August 2026, up 88% from 51 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 malfunction (89%), injury (10.2%) and death (0.8%); across all pulse-generator, pacemaker, external reports (product code DTE) death is recorded in 0.7% and malfunction in 91.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are output problem (18.2%), mechanical problem (10.5%) and no device output (10.5%). The patient problems coded most often are no patient involvement, asystole and cardiac arrest. 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 13,075 reports carrying product code DTE. 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 |
|---|---|---|---|
| Output problem | 66 | 18.2% | 5.5% |
| Mechanical problema mechanical problem | 38 | 10.5% | 12.7% |
| No device output | 38 | 10.5% | 3.3% |
| Calibration problem | 28 | 7.7% | 4.8% |
| Connection problema connection problem | 27 | 7.4% | 20.2% |
| No display/image | 26 | 7.2% | 10.1% |
| Electrical /electronic property probleman electrical or electronic problem | 25 | 6.9% | 2.4% |
| Device sensing problem | 22 | 6.1% | 3.6% |
| Unexpected shutdown | 22 | 6.1% | 2.4% |
| Display or visual feedback problem | 18 | 5% | 4.8% |
| Battery problema problem with the battery | 15 | 4.1% | 1.2% |
| Failure to capture | 14 | 3.9% | 1.5% |
| Failure to power up | 10 | 2.8% | 4.4% |
| Corrodedthe device corroded | 7 | 1.9% | 1.2% |
| Capturing problem | 6 | 1.7% | 0.4% |
| Loose or intermittent connection | 4 | 1.1% | 0.9% |
| Output below specifications | 4 | 1.1% | 0.3% |
| Pacing intermittently | 4 | 1.1% | 0.4% |
| Pacing problem | 4 | 1.1% | 3.1% |
| Breakthe device broke | 3 | 0.8% | 3.8% |
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 |
|---|---|---|
| No patient involvement | 28 | 7.7% |
| Asystole | 5 | 1.4% |
| Cardiac arrestthe heart stopped | 5 | 1.4% |
| Bradycardiaslow heart rate | 4 | 1.1% |
| Arrhythmia | 3 | 0.8% |
| Heart block | 3 | 0.8% |
| Diaphoresis | 2 | 0.6% |
| Non specific ekg/ECG changes | 2 | 0.6% |
| Tachycardiafast heart rate | 2 | 0.6% |
| Complete heart block | 1 | 0.3% |
| Deaththe patient died; cause not stated by this term | 1 | 0.3% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.3% |
| Injurya physical injury | 1 | 0.3% |
| Low blood pressure/ hypotension | 1 | 0.3% |
| Multiple organ dysfunction syndromeseveral organs failing | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Temporary External Pacemaker | Product code DTE | All MAUDE reports |
|---|---|---|---|
| Reports | 363 | 13,075 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 8 | 7 | 9 |
| Classified as injury | 10.2% | 7.7% | 36.2% |
| Classified as malfunction | 89% | 91.1% | 62.3% |
| Filed by the manufacturer | 100% | 98.1% | 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 DTE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dual Chamber Temporary Pacemaker | 5,828 | 518 | 0.3% |
| Asku | 4,752 | 210 | 1.1% |
| Medtronic | 2,953 | 17 | 4.4% |
| Pacemaker | 221 | 15 | 5.9% |
| Medtronic Lead | 2,351 | 328 | 9.5% |
| CapSureFix Novus Lead MRI SureScan | 108,103 | 17,554 | 1% |
| CapSureFix Novus MRI SureScan | 18,909 | 3,243 | 1.3% |
| Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses | 824 | 0 | 3.8% |
| Evera Xt Vr | 1,475 | 91 | 4.1% |
| Zoll | 221 | 0 | 14% |
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 Temporary External Pacemaker reports
How many FDA reports name Temporary External Pacemaker?
363 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 96 in the latest 12 months.
What kinds of events are reported?
malfunction (89%), injury (10.2%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
output problem (18.2%), mechanical problem (10.5%), no device output (10.5%), calibration problem (7.7%) and connection problem (7.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Temporary External Pacemaker 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.