Permanent defibrillator electrodes: medical device reports filed with FDA

138,578 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.

138,578
reports with this product code: 0.5% of all MAUDE reports; 11,263
reports, 12 months to August 2026: 11,244 in the 12 months before; 41.2%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

Product code NVY is FDA's classification for "Permanent defibrillator electrodes" (unknown panel), a class 3 device. 138,578 medical device reports carry this product code, 0.5% of the MAUDE database, from July 1997 to August 2026.

11,263 reports arrived in the 12 months to August 2026, close to the 11,244 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 (56.5%), malfunction (41.2%) 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
Durata Sts Optim Active Fixation Df-4 Connector	27,823	1,784	3.9%	30.9%
Endotak Reliance	14,711	238	1.2%	30.7%
Riata Active Fixation	11,664	96	1.8%	46.8%
Sprint Quattro Secure MRI SureScan	6,890	1,903	1.4%	39.9%
Optisure Active Fixation Df-4 Connector	6,560	623	4.3%	26.9%
Endotak Reliance Sg	6,094	1,083	0.5%	43.1%
Sprint Quattro Secure	4,668	2	5.2%	31.7%
Riata St Active Fixation	4,582	76	2.2%	42.2%
Reliance 4-Front	4,360	2,024	0.4%	35.1%
Isoflex Optim Lead	4,055	437	2%	51.8%
Durata Sts Optim Active Fixation	3,947	301	5.6%	33.6%
Riata Passive Fixation	3,666	32	1.2%	42.9%
Endotak Reliance G	2,618	1,049	0.6%	39.1%
Plexa ProMRI S 65	2,520	245	0.6%	58.8%
Permanent Defibrillator Electrodes	2,438	230	0.6%	74.3%
Epsila EV MRI SureScan	1,869	1,023	1%	38.3%
Linox Smart S DX 65/15	1,202	113	0.5%	61.2%
Durata Sts Optim Passive Fixation Df-4 Connector	1,157	36	2.1%	37.6%
Protego ProMRI S 65	1,103	76	0.6%	61.7%
Durata Sts Optim Active Fixation Df4 Connector	926	0	5.1%	36.9%
Plexa ProMRI S DX 65/15	909	130	0.1%	54.2%
Riata St Optim Active Fixation	891	14	7.2%	25.3%
Riata St Passive Fixation	875	23	1.4%	37.1%
Linox S 65	849	25	0.6%	79.2%
Plexa ProMRI DF-1 S DX 65/15	843	93	0%	64.3%
Linox SD 65/16	835	31	1.2%	66.3%
S-Icd System	766	0	1.1%	30.3%
Linox SD 65/18	740	24	1.1%	71.1%
Linox Smart S 65	696	26	0.7%	66.8%
Riata ST Optim Lead	683	24	8.2%	41%

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	23,804	17.2%
Biotronik Se & Kg	18,984	13.7%
Cpi - Del Caribe	14,566	10.5%
Boston Scientific	14,195	10.2%
St Jude Medical Crm-Sunnyvale	12,410	9%
St Jude Medical Cardiac Rhythm Management Division	12,145	8.8%
Mpri	10,416	7.5%
St Jude Medical Crmd	9,386	6.8%
Abbott	6,513	4.7%
St Jude Medical	3,414	2.5%
Medtronic Puerto Rico Villalba	2,697	1.9%
St Jude Medical Crm-Kista	1,663	1.2%
Medtronic	1,532	1.1%
Abbott Medical Crm-Sylmar	1,271	0.9%
Cameron Health	784	0.6%

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%3,088

Injury56.5%78,253

Malfunction41.2%57,132

Other0%26

Not given0.1%79

Who filed

Manufacturer report97.3%134,810

Voluntary report2.7%3,699

User facility report0%0

Distributor report0%1

Not given0%68

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

Device problems coded

Device problem (FDA code)	Reports	Share
Over-sensing	31,647	22.8%
High impedance	27,781	20%
Device dislodged or dislocated	15,139	10.9%
Breakthe device broke	12,200	8.8%
Inappropriate/inadequate shock/stimulation	11,723	8.5%
Failure to capture	11,211	8.1%
High capture threshold	11,179	8.1%
Signal artifact/noise	9,177	6.6%
Low impedance	8,320	6%
Fracturea broken bone	7,464	5.4%
Device sensing problem	6,907	5%
Capturing problem	5,184	3.7%
Ambient noise problem	5,111	3.7%
Impedance problem	4,273	3.1%
Under-sensing	3,474	2.5%
Insufficient device problem information	2,892	2.1%
Pacing problem	2,845	2.1%
Decreased sensitivity	2,713	2%
Material integrity problema problem with the device material	1,531	1.1%
Low sensing threshold	1,508	1.1%

Questions about permanent defibrillator electrodes reports

What is product code NVY?

FDA's classification code for "Permanent defibrillator 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?

138,578 reports through August 2026, 11,263 of them in the latest 12 months.

Which brands appear most often?

Durata Sts Optim Active Fixation Df-4 Connector (27,823), Endotak Reliance (14,711), Riata Active Fixation (11,664), Sprint Quattro Secure MRI SureScan (6,890) and Optisure Active Fixation Df-4 Connector (6,560). 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.