Pulse-generator, pacemaker, external: medical device reports filed with FDA

13,075 reports carry this product code, 1992–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

13,075
reports with this product code: 0.1% of all MAUDE reports; 614
reports, 12 months to August 2026: 614 in the 12 months before; 91.1%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

Product code DTE is FDA's classification for "Pulse-generator, pacemaker, external" (cardiovascular panel), a class 2 device. 13,075 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1992 to August 2026.

614 reports arrived in the 12 months to August 2026, close to the 614 of 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 (91.1%), injury (7.7%) and death (0.7%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Dual Chamber Temporary Pacemaker	5,155	518	0.3%	95.1%
Asku	2,197	210	1.1%	47.1%
Temporary External Pacemaker	363	96	0.8%	89%
Medtronic	7	17	4.4%	23.5%
Pacemaker	4	15	5.9%	18.1%
Medtronic Lead	2	328	9.5%	34.3%
CapSureFix Novus Lead MRI SureScan	1	17,554	1%	55.5%
CapSureFix Novus MRI SureScan	1	3,243	1.3%	54.5%
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses	1	0	3.8%	4.9%
Evera Xt Vr	1	91	4.1%	33.6%
Zoll	1	0	14%	36.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic	4,861	37.2%
Plexus Manufacturing Sdn Bhd	3,967	30.3%
Medtronic Milaca	3,767	28.8%
Rice Creek Mfg	39	0.3%
Zoll Medical	13	0.1%
Medtronic Cardiac Rhythm Management Division	10	0.1%
Bio-Detek	5	0%
Biotronik And	5	0%
Physio-Control	3	0%
Telectronics Pacing Systems	3	0%
Biotronik	2	0%
Biotronik Se & Kg	2	0%
Medtronic Singapore Operations	2	0%
Oscor	2	0%
Cordis	1	0%

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 and report source

Event type

Death0.7%87

Injury7.7%1,006

Malfunction91.1%11,913

Other0.3%38

Not given0.2%31

Who filed

Manufacturer report98.1%12,826

Voluntary report0.7%87

User facility report0%0

Distributor report0%4

Not given1.2%158

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Connection problema connection problem	2,643	20.2%
Mechanical problema mechanical problem	1,659	12.7%
No display/image	1,318	10.1%
Output problem	719	5.5%
Calibration problem	634	4.8%
Display or visual feedback problem	623	4.8%
Failure to power up	576	4.4%
Breakthe device broke	493	3.8%
Device sensing problem	476	3.6%
No device output	432	3.3%
Device displays incorrect message	421	3.2%
Pacing problem	407	3.1%
Loss of powerthe device lost power	397	3%
Electrical /electronic property probleman electrical or electronic problem	317	2.4%
Unexpected shutdown	310	2.4%
Component missing	250	1.9%
Material integrity problema problem with the device material	205	1.6%
Nonstandard device	205	1.6%
Failure to capture	199	1.5%
Contamination	175	1.3%

Questions about pulse-generator, pacemaker, external reports

What is product code DTE?

FDA's classification code for "Pulse-generator, pacemaker, external", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

13,075 reports through August 2026, 614 of them in the latest 12 months.

Which brands appear most often?

Dual Chamber Temporary Pacemaker (5,155), Asku (2,197), Temporary External Pacemaker (363), Medtronic (7) and Pacemaker (4). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.