Device manufacturer, as written on reports

St Jude Medical Cardiac Rhythm Management Division: medical device reports filed with FDA

55,536 reports name it as the manufacturer of the device involved, 1998–2021.

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.

55,536
reports naming it as manufacturer: 0.2% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 32.8%
classified as malfunction: 62.3% across all reports; 2.6%
classified as death, as reported: 0.9% across all reports

55,536 medical device reports received by FDA give St Jude Medical Cardiac Rhythm Management Division as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 1998 to April 2021. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (64.5%), malfunction (32.8%) and death (2.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Tendril Sdx	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	5,604	3	2.3%
Riata Active Fixation	Permanent defibrillator electrodes	5,520	96	1.8%
Tendril St	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	4,114	547	5.2%
Durata Sts Optim Active Fixation	Implantable cardioverter defibrillator (non-crt)	2,081	301	5.6%
Tendril Dx	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,841	69	2%
Riata St Active Fixation	Permanent defibrillator electrodes	1,821	76	2.2%
Durata Sts Optim Active Fixation Df-4 Connector	Permanent defibrillator electrodes	1,804	1,784	3.9%
Tendril Sts	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,738	4,320	3.1%
Riata Passive Fixation	Permanent defibrillator electrodes	1,517	32	1.2%
Isoflex S	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,240	0	1.7%
Quicksite Lv	Drug eluting permanent left ventricular (lv) pacemaker electrode	956	13	7.2%
Riata St Optim Active Fixation	Permanent defibrillator electrodes	755	14	7.2%
Quickflex Micro Lv Lead	Drug eluting permanent left ventricular (lv) pacemaker electrode	662	116	5.9%
Riata Active Fixation Lead	Implantable cardioverter defibrillator (non-crt)	640	0	0.9%
Optisense	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	589	22	7.7%
Quartet	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	553	848	5.2%
Quick Flex Lv Lead	Drug eluting permanent left ventricular (lv) pacemaker electrode	517	0	8.2%
Riata St Active Fixation Lead	Implantable cardioverter defibrillator (non-crt)	452	0	0.9%
Isoflex Optim Lead	Permanent defibrillator electrodes	422	437	2%
Durata Sts Optim Active Fixation Df4 Connector	Permanent defibrillator electrodes	375	0	5.1%
Durata Sts Optim Active Fixation Lead Df-4 Connecto	Permanent defibrillator electrodes	357	0	3.6%
Durata Sts Optim Active Fixation Lead	Permanent defibrillator electrodes	299	0	5.5%
Tempo	Implantable pacemaker pulse-generator	294	155	0.7%
Durata Sts Optim Active Fixation Sj4 Connector	Implantable cardioverter defibrillator (non-crt)	274	0	1.1%
Isoflex Lead	Permanent pacemaker electrode	270	0	0.9%
Atlas Plus Vr	Implantable cardioverter defibrillator (non-crt)	252	0	3.6%
Unify Crt-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	234	10	3.4%
Trilogy	Ventilator, continuous, facility use	216	663	0.4%
Quadra Assura Crt-D Df4 Connector	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	200	0	1%
Passive Plus Dx	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	191	22	3.9%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
DTB	Permanent pacemaker electrode	13,061	23.5%
NVY	Permanent defibrillator electrodes	12,145	21.9%
LWS	Implantable cardioverter defibrillator (non-crt)	9,125	16.4%
DXY	Implantable pacemaker pulse-generator	8,641	15.6%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	5,781	10.4%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	3,831	6.9%
LWP	Implantable pulse generator, pacemaker (non-crt)	1,813	3.3%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	684	1.2%
MXC	Recorder, event, implantable cardiac, (without arrhythmia detection)	197	0.4%
NVZ	Pulse generator, permanent, implantable	70	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

Death2.6%1,434

Injury64.5%35,831

Malfunction32.8%18,212

Other0%1

Not given0.1%58

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about St Jude Medical Cardiac Rhythm Management Division reports

How many FDA device reports name St Jude Medical Cardiac Rhythm Management Division as manufacturer?

55,536 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Tendril Sdx (5,604), Riata Active Fixation (5,520), Tendril St (4,114), Durata Sts Optim Active Fixation (2,081) and Tendril Dx (1,841).

Which device types does it report on?

permanent pacemaker electrode (23.5%), permanent defibrillator electrodes (21.9%), implantable cardioverter defibrillator (non-crt) (16.4%) and implantable pacemaker pulse-generator (15.6%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.