Pulse generator, permanent, implantable: medical device reports filed with FDA

95,612 reports carry this product code, 1997–2026; 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.

95,612
reports with this product code: 0.4% of all MAUDE reports; 5,698
reports, 12 months to August 2026: 6,227 in the 12 months before; 43.5%
classified as malfunction: 62.3% across all reports; 4.1%
classified as death, as reported: 0.9% across all reports

Product code NVZ is FDA's classification for "Pulse generator, permanent, implantable" (unknown panel), a class 3 device. 95,612 medical device reports carry this product code, 0.4% of the MAUDE database, from May 1997 to August 2026.

5,698 reports arrived in the 12 months to August 2026, close to the 6,227 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 injury (52.1%), malfunction (43.5%) and death (4.1%). 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
Adapta	4,892	279	7.4%	36.7%
Advisa MRI SureScan	3,589	272	1.9%	50.5%
Reply	2,491	9	1.5%	51.2%
Insignia	2,022	0	1.3%	43.9%
Altrua	1,705	0	2.4%	29.3%
Carelink	1,579	18	0%	97.9%
Sensia IPG	1,391	73	2.7%	27.7%
Dextrus 4136	1,284	0	0.8%	31.3%
Azure	919	0	1.8%	43.2%
MyCareLink Patient Monitor	887	47	0.1%	99.6%
Pulse Generator Permanent Implantable	842	24	1.1%	65.7%
Fortify Vr U1 6 Sj4 Us	833	8	1.2%	11.1%
Ellipse VR	711	45	3.7%	56.7%
Symphony	676	133	1.6%	42.3%
Fortify Assura VR ICD, US	664	213	2.3%	32.2%
Consulta Crt-P	648	5	4.7%	38.8%
Dextrus 4135	617	0	0.5%	23.5%
Dextrus 4137	565	0	1%	39.2%
Ingenio	549	493	0.8%	29.4%
Medtronic IPG	520	114	15.1%	34.8%
Versa Ipg	479	12	8.1%	43%
Enrhythm Mri	473	0	1%	16.3%
Fortify Assura Vr Icd Ide Us	453	0	1.8%	23.6%
Enrhythm	422	0	9.9%	20.2%
Fortify Vr U1 6 Df1 Us	419	10	1.6%	17%
Syncra CRT-P	396	7	4.8%	38.8%
Relia IPG	361	20	0.6%	11.6%
Setrox S 53	306	128	1.2%	47.5%
Merlin@home, RF telemetry basic	266	45	0.1%	98.4%
Mycarelink	205	0	0%	99%

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
St Jude Medical Crm-Sylmar	16,044	16.8%
Medtronic Singapore Operations	14,454	15.1%
Medtronic Puerto Rico Operations	11,971	12.5%
Medtronic Med Rel Medtronic Puerto Rico	7,864	8.2%
Biotronik Se & Kg	7,245	7.6%
Medtronic Europe Sarl	5,439	5.7%
Guidant Crm Clonmel Ireland	4,383	4.6%
Medtronic	4,378	4.6%
Medtronic Med Rel	3,989	4.2%
Ipg Mfg Switzerland	3,083	3.2%
St Jude Medical Crm-Sunnyvale	2,535	2.7%
Abbott	1,570	1.6%
St Jude Medical	1,288	1.3%
Sorin Crm	1,143	1.2%
Sorin Group Italia - Crm Facility	1,129	1.2%

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

Death4.1%3,915

Injury52.1%49,858

Malfunction43.5%41,635

Other0.1%142

Not given0.1%62

Who filed

Manufacturer report98.7%94,367

Voluntary report1.2%1,192

User facility report0%0

Distributor report0%2

Not given0.1%51

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

Device problems coded

Device problem (FDA code)	Reports	Share
Premature discharge of battery	10,782	11.3%
Pacing problem	10,046	10.5%
Over-sensing	5,364	5.6%
Battery problema problem with the battery	4,490	4.7%
Failure to interrogate	4,358	4.6%
Mechanical problema mechanical problem	3,729	3.9%
Failure to capture	3,275	3.4%
Inappropriate or unexpected reset	1,860	1.9%
Unable to obtain readings	1,785	1.9%
Insufficient device problem information	1,768	1.8%
Device dislodged or dislocated	1,663	1.7%
High impedance	1,619	1.7%
Incorrect measurementthe device measured wrongly	1,569	1.6%
Communication or transmission problemthe device could not communicate or transmit	1,463	1.5%
Pacemaker found in back-up mode	1,374	1.4%
Reset problem	1,324	1.4%
Inappropriate/inadequate shock/stimulation	1,312	1.4%
Device sensing problem	1,298	1.4%
Under-sensing	1,297	1.4%
Defective devicethe device was defective	1,293	1.4%

Questions about pulse generator, permanent, implantable reports

What is product code NVZ?

FDA's classification code for "Pulse generator, permanent, implantable", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

95,612 reports through August 2026, 5,698 of them in the latest 12 months.

Which brands appear most often?

Adapta (4,892), Advisa MRI SureScan (3,589), Reply (2,491), Insignia (2,022) and Altrua (1,705). 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.