Permanent pacemaker electrode: medical device reports filed with FDA

327,317 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.

327,317
reports with this product code: 1.3% of all MAUDE reports; 26,060
reports, 12 months to August 2026: 25,701 in the 12 months before; 43.9%
classified as malfunction: 62.3% across all reports; 2.9%
classified as death, as reported: 0.9% across all reports

Product code DTB is FDA's classification for "Permanent pacemaker electrode" (cardiovascular panel), a class 3 device. 327,317 medical device reports carry this product code, 1.3% of the MAUDE database, from January 1992 to August 2026.

26,060 reports arrived in the 12 months to August 2026, close to the 25,701 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 (53.1%), malfunction (43.9%) and death (2.9%). 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
CapSureFix Novus Lead MRI SureScan	108,100	17,554	1%	55.5%
Capsurefix Novus	57,525	4	6.8%	38.1%
CapSureFix Novus MRI SureScan	18,806	3,243	1.3%	54.5%
CapSure Sense Lead MRI SureScan	8,774	1,337	1%	51.9%
CapSure SP	8,223	226	3.9%	31.3%
Capsurefix	5,810	0	6.3%	27.5%
Permanent Pacemaker Electrode	4,936	332	0.4%	69.7%
Capsure Sp Novus	4,792	0	9.5%	28.7%
Capsure Sense	4,732	0	6.4%	39.1%
Flextend	4,541	203	0.7%	18.4%
Attain Otw	4,175	0	9.1%	35.3%
Tendril Sdx	3,994	3	2.3%	36.1%
CapSure Epicardial Lead	3,874	760	1.5%	36.7%
Tendril Sts	2,746	4,320	3.1%	43.3%
CapSure SP Novus Lead	2,709	331	1.1%	51.3%
Tendril St	2,625	547	5.2%	45.7%
Capsure Z Novus	2,577	0	5.9%	27.4%
CapSure Z Novus Lead	2,215	313	0.4%	42.8%
CapSureFix Lead	2,095	358	0.8%	48.4%
Flextend Is-1 Bi Positive Fix	1,910	0	1.2%	24.5%
Capsure EPI	1,531	0	7%	23.6%
Accufix	1,452	0	0.8%	43.9%
Capsureepi	1,448	0	2.4%	25%
Tendril Dx	1,446	69	2%	35.1%
Dextrus 4136	1,407	0	0.8%	31.3%
Endotak Reliance	1,276	238	1.2%	30.7%
Screw-In Lead	1,187	163	0.6%	36.1%
Myocardial Lead	1,164	2	3%	28.6%
CapSure Z	1,154	38	3.7%	30.5%
Screw-In	998	0	13.1%	22.4%

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
Mpri	154,752	47.3%
Medtronic Puerto Rico	38,652	11.8%
Medtronic Singapore Operations	25,562	7.8%
Medtronic Puerto Rico Villalba	24,616	7.5%
Cpi - Del Caribe	13,267	4.1%
St Jude Medical Cardiac Rhythm Management Division	13,061	4%
Medtronic	12,694	3.9%
Boston Scientific	9,504	2.9%
Cardiac Pacemakers	8,343	2.5%
St Jude Medical Crmd	3,844	1.2%
Telectronics Pacing Systems	2,540	0.8%
Biotronik And	2,124	0.6%
Biotronik Se & Kg	2,100	0.6%
St Jude Medical	1,509	0.5%
Greatbatch Medical	1,483	0.5%

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

Death2.9%9,390

Injury53.1%173,763

Malfunction43.9%143,557

Other0.1%385

Not given0.1%222

Who filed

Manufacturer report96.8%316,810

Voluntary report2.6%8,372

User facility report0%0

Distributor report0.1%197

Not given0.6%1,938

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

Device problems coded

Device problem (FDA code)	Reports	Share
Under-sensing	55,970	17.1%
Over-sensing	43,326	13.2%
High capture threshold	40,137	12.3%
High impedance	35,167	10.7%
Failure to capture	31,790	9.7%
Device dislodged or dislocated	29,900	9.1%
Low impedance	17,236	5.3%
Signal artifact/noise	17,042	5.2%
Pacing problem	16,507	5%
Fracturea broken bone	15,745	4.8%
Impedance problem	14,090	4.3%
Capturing problem	13,722	4.2%
Decreased sensitivity	7,723	2.4%
High sensing threshold	7,501	2.3%
Positioning problem	7,329	2.2%
Electrical /electronic property probleman electrical or electronic problem	6,892	2.1%
Device sensing problem	6,084	1.9%
Breakthe device broke	5,767	1.8%
Dislodged	5,734	1.8%
Activation, positioning or separation problem	5,001	1.5%

Questions about permanent pacemaker electrode reports

What is product code DTB?

FDA's classification code for "Permanent pacemaker electrode", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

327,317 reports through August 2026, 26,060 of them in the latest 12 months.

Which brands appear most often?

CapSureFix Novus Lead MRI SureScan (108,100), Capsurefix Novus (57,525), CapSureFix Novus MRI SureScan (18,806), CapSure Sense Lead MRI SureScan (8,774) and CapSure SP (8,223). 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.