Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes: medical device reports filed with FDA

229,796 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.

229,796
reports with this product code: 0.9% of all MAUDE reports; 23,441
reports, 12 months to August 2026: 22,763 in the 12 months before; 41.6%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code NVN is FDA's classification for "Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes" (unknown panel), a class 3 device. 229,796 medical device reports carry this product code, 0.9% of the MAUDE database, from May 1997 to August 2026.

23,441 reports arrived in the 12 months to August 2026, close to the 22,763 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 (56.2%), malfunction (41.6%) and death (2.2%). 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
Tendril Sts	51,220	4,320	3.1%	43.3%
SelectSecure MRI SureScan	20,957	4,994	1.3%	46.1%
Tendril St	17,504	547	5.2%	45.7%
Ingevity Mri	17,093	1,749	0.3%	29.2%
Ingevity+	15,339	2,150	0.3%	21.9%
Tendril Sdx Lead	9,377	431	4.5%	39.1%
CapSure Fix MRI	5,749	600	0.6%	54.8%
Solia S 53	4,995	647	0.5%	49.8%
Tendril Mri	4,638	422	4.1%	36.1%
Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele	4,453	405	0.3%	70.2%
Capsurefix Mri Surescan	4,240	0	2.8%	34.5%
Tendril Sdx	4,228	3	2.3%	36.1%
Ingevity	3,779	299	0.9%	30.6%
Ingevity +	3,053	2,281	0.6%	35.8%
Dextrus 4136	2,997	0	0.8%	31.3%
Isoflex Optim Lead	2,980	437	2%	51.8%
Setrox S 53	2,908	128	1.2%	47.5%
Solia S 60	2,666	495	0.5%	56.7%
Optisense Lead	2,609	143	4.8%	48.6%
Tendril Dx	2,600	69	2%	35.1%
Selectsecure	2,490	0	0.9%	45.3%
Capsurefix Novus Mri	2,420	0	2.9%	37.3%
Flextend	2,292	203	0.7%	18.4%
Solia S 45	2,038	241	0.5%	48.9%
Dextrus 53 Model 4136 US 644136-102	1,845	155	0.4%	63.7%
Isoflex S Lead	1,619	64	4.4%	47.2%
Dextrus 4135	1,357	0	0.5%	23.5%
Dextrus 4137	1,275	0	1%	39.2%
Capsurefix	1,183	0	6.3%	27.5%
UltiPace Lead, 52cm MRI	1,109	673	1.8%	24.7%

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
St Jude Medical Crm-Sylmar	66,552	29%
Boston Scientific	37,025	16.1%
Mpri	28,511	12.4%
Biotronik Se & Kg	26,700	11.6%
Cpi - Del Caribe	12,033	5.2%
St Jude Medical Crm-Sunnyvale	9,584	4.2%
St Jude Medical Crmd	8,561	3.7%
Abbott	7,056	3.1%
Medtronic Puerto Rico Villalba	6,320	2.8%
St Jude Medical Cardiac Rhythm Management Division	5,781	2.5%
Medtronic	5,128	2.2%
St Jude Medical	4,220	1.8%
Abbott Medical Crm-Sylmar	3,417	1.5%
Medtronic Puerto Rico	2,614	1.1%
St Jude Medical Crm-Kista	914	0.4%

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

Death2.2%5,070

Injury56.2%129,085

Malfunction41.6%95,491

Other0%51

Not given0%99

Who filed

Manufacturer report96.9%222,578

Voluntary report3.1%7,121

User facility report0%0

Distributor report0%12

Not given0%85

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

Device problems coded

Device problem (FDA code)	Reports	Share
Over-sensing	41,168	17.9%
Device dislodged or dislocated	36,240	15.8%
Failure to capture	29,015	12.6%
High capture threshold	24,628	10.7%
High impedance	20,985	9.1%
Signal artifact/noise	20,660	9%
Breakthe device broke	11,933	5.2%
Low impedance	11,678	5.1%
Fracturea broken bone	10,807	4.7%
Capturing problem	10,776	4.7%
Under-sensing	10,412	4.5%
Pacing problem	10,093	4.4%
Device sensing problem	8,539	3.7%
Insufficient device problem information	5,908	2.6%
Impedance problem	5,028	2.2%
Material integrity problema problem with the device material	4,990	2.2%
Failure to sense	4,709	2%
Defective devicethe device was defective	3,809	1.7%
Positioning problem	3,660	1.6%
Mechanical problema mechanical problem	3,427	1.5%

Questions about drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes reports

What is product code NVN?

FDA's classification code for "Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

229,796 reports through August 2026, 23,441 of them in the latest 12 months.

Which brands appear most often?

Tendril Sts (51,220), SelectSecure MRI SureScan (20,957), Tendril St (17,504), Ingevity Mri (17,093) and Ingevity+ (15,339). 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.