Implantable pacemaker pulse-generator: medical device reports filed with FDA

57,832 reports carry this product code, 1991–2026; 30 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.

57,832
reports with this product code: 0.2% of all MAUDE reports; 918
reports, 12 months to August 2026: 827 in the 12 months before; 41.2%
classified as malfunction: 62.3% across all reports; 3.4%
classified as death, as reported: 0.9% across all reports

Product code DXY is FDA's classification for "Implantable pacemaker pulse-generator" (cardiovascular panel), a class 3 device. 57,832 medical device reports carry this product code, 0.2% of the MAUDE database, from December 1991 to August 2026.

918 reports arrived in the 12 months to August 2026, up 11% from 827 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 (54.4%), malfunction (41.2%) and death (3.4%). 30 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
Tendril Mri	2,435	422	4.1%	36.1%
Medtronic Lead	2,286	328	9.5%	34.3%
Carelink Program W/Telemetry C	1,678	0	0%	99.2%
Carelink	1,109	18	0%	97.9%
Assurity Mri	1,016	2,035	1.8%	34.4%
Insignia Plus	921	0	9.1%	38.5%
Insignia Ultra	782	0	5.4%	29.9%
Meta Dddr	532	0	0.4%	28.8%
Enpulse	519	3	10.4%	28.9%
Medtronic ICD	393	105	23.8%	14.9%
Insignia Entra	373	0	10.2%	33.2%
Anthem Rf	326	0	4.3%	77.4%
Tempo	317	155	0.7%	58.3%
Medtronic	310	17	4.4%	23.5%
Symphony	308	133	1.6%	42.3%
Insignia I Plus Dddro Is-1	290	0	0.9%	36.6%
Altrua 60 Dddr Is-1 - Eu Market Released	288	0	0%	22.1%
Insignia I Ultra Dddro Is-1	287	0	0%	31.3%
Sigma 100 Vvi	272	0	1.4%	7.6%
Capsure Z Novus	271	0	5.9%	27.4%
Trilogy	268	663	0.4%	88.2%
Sweet Tip Bipolar Lead	254	0	0%	16.1%
CapSure VDD-2 Lead	212	23	0.5%	34%
Capsure Vdd 2	206	0	1.5%	34.5%
Relay	203	0	1%	85.2%
Alizea	187	50	0.7%	97.5%
Integrity Micro	185	0	0%	31.7%
Sigma 100 S	174	0	1.8%	6.3%
At500	170	0	0.6%	17.3%
Reply	169	9	1.5%	51.2%

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	10,366	17.9%
St Jude Medical Cardiac Rhythm Management Division	8,641	14.9%
Medtronic Med Rel	7,839	13.6%
Cardiac Pacemakers	5,245	9.1%
St Jude Medical Crmd	4,602	8%
St Jude Medical Crm-Sylmar	2,660	4.6%
Guidant Crm Clonmel Ireland	2,162	3.7%
Telectronics Pacing Systems	1,361	2.4%
St Jude Medical Crm-Sunnyvale	1,055	1.8%
Rice Creek Mfg	976	1.7%
Pacesetter	838	1.4%
St Jude Medical Cardiac Rhythm Management Divisi	703	1.2%
Ipg Mfg Switzerland	621	1.1%
Medtronic Puerto Rico	582	1%
Sulzer Intermedics	572	1%

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

Death3.4%1,957

Injury54.4%31,484

Malfunction41.2%23,825

Other0.7%385

Not given0.3%181

Who filed

Manufacturer report96.6%55,865

Voluntary report1.4%810

User facility report0%0

Distributor report0.1%86

Not given1.9%1,071

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

Device problems coded

Device problem (FDA code)	Reports	Share
Premature discharge of battery	4,831	8.4%
Pacing problem	3,709	6.4%
Failure to capture	3,651	6.3%
Pacemaker found in back-up mode	3,536	6.1%
Failure to interrogate	3,506	6.1%
Over-sensing	3,121	5.4%
Low battery	3,048	5.3%
No device output	2,763	4.8%
Other (for use when an appropriate device code cannot be identified)	2,610	4.5%
High impedance	2,206	3.8%
Explanted	1,905	3.3%
Difficult to interrogate	1,770	3.1%
Telemetry discrepancy	1,321	2.3%
Premature elective replacement indicator	1,276	2.2%
Device displays incorrect message	1,229	2.1%
Normal	1,157	2%
Malfunction	1,075	1.9%
Device operates differently than expectedthe device behaved unexpectedly	1,066	1.8%
Device dislodged or dislocated	1,051	1.8%
Signal artifact/noise	997	1.7%

Questions about implantable pacemaker pulse-generator reports

What is product code DXY?

FDA's classification code for "Implantable pacemaker pulse-generator", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

57,832 reports through August 2026, 918 of them in the latest 12 months.

Which brands appear most often?

Tendril Mri (2,435), Medtronic Lead (2,286), Carelink Program W/Telemetry C (1,678), Carelink (1,109) and Assurity Mri (1,016). 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.