Implantable pulse generator, pacemaker (non-crt): medical device reports filed with FDA

157,494 reports carry this product code, 1992–2026; 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.

157,494
reports with this product code: 0.6% of all MAUDE reports; 18,278
reports, 12 months to August 2026: 10,329 in the 12 months before; 41.5%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

Product code LWP is FDA's classification for "Implantable pulse generator, pacemaker (non-crt)" (unknown panel), a class 3 device. 157,494 medical device reports carry this product code, 0.6% of the MAUDE database, from July 1992 to August 2026.

18,278 reports arrived in the 12 months to August 2026, up 77% from 10,329 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 (57.3%), malfunction (41.5%) and death (1.2%). 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
Assurity Mri	17,974	2,035	1.8%	34.4%
Teligen	10,066	47	0.6%	36.7%
Ingenio	6,581	493	0.8%	29.4%
Cognis	4,760	6	1.5%	41%
Ingevity	4,528	299	0.9%	30.6%
Accolade	3,812	4	1.5%	36.3%
Attain Otw	3,592	0	9.1%	35.3%
Energen	3,287	0	0.6%	41.2%
Energen Icd	3,148	142	0.2%	23.6%
ACUITY X4 Spiral S	2,815	424	0.5%	38.8%
ACUITY X4 Straight	2,672	382	0.4%	29.9%
Incepta Icd	2,495	126	0.1%	23.3%
Altrua	2,370	0	2.4%	29.3%
Incepta	2,343	0	0.7%	39%
Revo MRI SureScan	1,993	12	2.9%	33.8%
Acuity	1,773	6	1%	24.8%
Insignia	1,679	0	1.3%	43.9%
Endurity Mri	1,531	159	1.2%	29.7%
Advantio	1,442	192	0.3%	30.4%
ACUITY X4 Spiral L	1,050	176	0.4%	42%
Attain Bipolar Over The Wire Lead	1,049	97	1.9%	35.3%
Altrua 60	970	29	0.6%	32.2%
Vitalio	819	185	0.2%	22%
Energen Crt-D	671	6	0.7%	32.3%
Dual Chamber Temporary Pacemaker	670	518	0.3%	95.1%
Incepta Crt-D	651	9	0.8%	31.4%
Kora	626	21	0%	98.9%
Eno	426	43	0%	97.4%
Attain Over The Wire Lead	425	51	2.4%	32.5%
Punctua Icd	414	10	0%	18.8%

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
Boston Scientific	65,101	41.3%
Guidant Crm Clonmel Ireland	28,114	17.9%
St Jude Medical Crm-Sylmar	20,564	13.1%
Cpi - Del Caribe	6,657	4.2%
Medtronic Milaca	5,915	3.8%
Abbott	5,905	3.7%
Mpri	4,875	3.1%
St Jude Medical Crmd	2,764	1.8%
Medtronic	2,285	1.5%
Ipg Mfg Switzerland	1,981	1.3%
St Jude Medical Crm-Sunnyvale	1,937	1.2%
St Jude Medical Cardiac Rhythm Management Division	1,813	1.2%
Medtronic Med Rel Medtronic Puerto Rico	1,405	0.9%
Microport Crm	1,281	0.8%
Cpi Plant - St Paul	1,069	0.7%

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

Death1.2%1,862

Injury57.3%90,168

Malfunction41.5%65,426

Other0%13

Not given0%25

Who filed

Manufacturer report99.3%156,464

Voluntary report0.5%751

User facility report0%0

Distributor report0%2

Not given0.2%277

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

Device problems coded

Device problem (FDA code)	Reports	Share
Premature discharge of battery	35,188	22.3%
High impedance	14,246	9%
Over-sensing	13,184	8.4%
Device displays incorrect message	12,503	7.9%
Pacing problem	8,781	5.6%
Failure to capture	8,390	5.3%
Incorrect, inadequate or imprecise result or readings	6,730	4.3%
Defective devicethe device was defective	5,528	3.5%
Battery problema problem with the battery	5,400	3.4%
Pacemaker found in back-up mode	5,058	3.2%
Signal artifact/noise	4,893	3.1%
Device operates differently than expectedthe device behaved unexpectedly	4,646	2.9%
High capture threshold	4,049	2.6%
Device dislodged or dislocated	3,611	2.3%
Device sensing problem	3,450	2.2%
Under-sensing	3,253	2.1%
Ambient noise problem	3,209	2%
Low impedance	3,117	2%
Failure to interrogate	2,841	1.8%
Capturing problem	2,835	1.8%

Questions about implantable pulse generator, pacemaker (non-crt) reports

What is product code LWP?

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

How many reports carry this code?

157,494 reports through August 2026, 18,278 of them in the latest 12 months.

Which brands appear most often?

Assurity Mri (17,974), Teligen (10,066), Ingenio (6,581), Cognis (4,760) and Ingevity (4,528). 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.