Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p): medical device reports filed with FDA

14,671 reports carry this product code, 2004–2026; 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.

14,671
reports with this product code: 0.1% of all MAUDE reports; 2,994
reports, 12 months to August 2026: 1,559 in the 12 months before; 43.9%
classified as malfunction: 62.3% across all reports; 1.9%
classified as death, as reported: 0.9% across all reports

Product code NKE is FDA's classification for "Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)" (unknown panel), a class 3 device. 14,671 medical device reports carry this product code, 0.1% of the MAUDE database, from May 2004 to August 2026.

2,994 reports arrived in the 12 months to August 2026, up 92% from 1,559 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 (54.1%), malfunction (43.9%) and death (1.9%). 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
Valitude X4 Crt-P	2,133	834	0.8%	38.3%
Visionist X4 Crt-P	1,776	877	0.2%	51%
Percepta Quad CRT-P MRI SureScan	1,539	261	2.3%	48.7%
Quadra Allure MP CRT-P	1,278	205	2.2%	60.3%
Invive	734	4	0.1%	10.7%
Visionist Crt-P	623	278	0.6%	52.6%
Valitude Crt-P	595	221	0.3%	45.4%
Percepta CRT-P MRI SureScan	549	97	1.3%	42.6%
Accolade	479	4	1.5%	36.3%
Quadra Allure MP RF CRT-P	392	17	6.1%	58.2%
Contak Renewal Tr	361	0	3.5%	37.6%
Percepta Quad Crtp	327	0	0%	35%
Anthem Rf Crt-P	300	0	7.3%	57.3%
Solara Quad CRT-P MRI SureScan	273	40	2.2%	42.9%
Allure Quadra RF CRT-P	267	6	5.9%	60.9%
Intua	250	5	0%	11.1%
Serena Quad CRT-P MRI SureScan	241	38	1.7%	42.3%
Ingenio	224	493	0.8%	29.4%
Solara CRT-P MRI SureScan	162	22	3.7%	48.1%
Allure RF	108	43	3%	58.6%
Corox Otw-S 85-Bp	74	4	1.4%	39.6%
Corox Otw-S 75-Bp	62	0	1.3%	40.9%
Corox Otw 85-Bp	60	0	0.5%	43.5%
Anthem Rf	46	0	4.3%	77.4%
Corox OTW-L 85-BP	37	5	1.1%	43.1%
Corox Otw-L 75-Bp	31	1	0.6%	45.5%
Reply	13	9	1.5%	51.2%
Contak Renewal	6	0	4.8%	60.4%
Consulta Crt-P	3	5	4.7%	38.8%
Pacemaker	3	15	5.9%	18.1%

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 Europe Sarl	2,207	15%
St Jude Medical Crm-Sylmar	1,662	11.3%
Boston Scientific	1,593	10.9%
Guidant Crm Clonmel Ireland	1,136	7.7%
Biotronik Se & Kg	611	4.2%
St Jude Medical Crm-Sunnyvale	234	1.6%
Cardiac Pacemakers	122	0.8%
St Jude Medical Crmd	120	0.8%
Abbott Medical Crm-Sylmar	90	0.6%
St Jude Medical Crm-Kista	71	0.5%
Ipg Mfg Switzerland	46	0.3%
St Jude Medical Cardiac Rhythm Management Division	42	0.3%
Biotronik And	23	0.2%
Biotronik	14	0.1%
Guidant Puerto Rico	13	0.1%

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

Death1.9%272

Injury54.1%7,939

Malfunction43.9%6,438

Other0.1%20

Not given0%2

Who filed

Manufacturer report98.9%14,506

Voluntary report0.9%131

User facility report0%0

Distributor report0%0

Not given0.2%34

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

Device problems coded

Device problem (FDA code)	Reports	Share
Premature discharge of battery	2,711	18.5%
Incorrect, inadequate or imprecise result or readings	1,601	10.9%
Over-sensing	1,532	10.4%
Pacing problem	1,322	9%
High impedance	914	6.2%
Failure to capture	621	4.2%
Signal artifact/noise	602	4.1%
Interrogation problem	399	2.7%
Defective devicethe device was defective	338	2.3%
Battery problema problem with the battery	314	2.1%
Pacemaker found in back-up mode	290	2%
Inappropriate or unexpected reset	287	2%
Low impedance	255	1.7%
Device operates differently than expectedthe device behaved unexpectedly	252	1.7%
Unable to obtain readings	243	1.7%
Data problem	237	1.6%
Under-sensing	229	1.6%
Mechanical problema mechanical problem	224	1.5%
High capture threshold	218	1.5%
Insufficient device problem information	196	1.3%

Questions about pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) reports

What is product code NKE?

FDA's classification code for "Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

14,671 reports through August 2026, 2,994 of them in the latest 12 months.

Which brands appear most often?

Valitude X4 Crt-P (2,133), Visionist X4 Crt-P (1,776), Percepta Quad CRT-P MRI SureScan (1,539), Quadra Allure MP CRT-P (1,278) and Invive (734). 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.