Device manufacturer, as written on reports
St Jude Medical: medical device reports filed with FDA
61,640 reports name it as the manufacturer of the device involved, 1992–2026.
- 61,640
- reports naming it as manufacturer
- 0.2% of all MAUDE reports
- 74
- reports, 12 months to August 2026
- 1,855 in the 12 months before
- 38.2%
- classified as malfunction
- 62.3% across all reports
- 1.8%
- classified as death, as reported
- 0.9% across all reports
61,640 medical device reports received by FDA give St Jude Medical as the manufacturer of the device involved, 0.2% of the MAUDE database, from July 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
74 reports arrived in the 12 months to August 2026, down 96% from 1,855 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 (59.6%), malfunction (38.2%) and death (1.8%). 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 |
|---|---|---|---|---|
| Unify Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 3,069 | 10 | 3.4% |
| HF Sensor Delivery System | System, hemodynamic, implantable | 2,908 | 757 | 4% |
| Quadra Assura Crt-D Quad Rf Hv | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 2,349 | 14 | 2.5% |
| Cardiomems Patient Electronic System | System, hemodynamic, implantable | 2,298 | 738 | 0% |
| Unify Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,805 | 127 | 1.6% |
| Quadra Assura MP ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,626 | 507 | 2.1% |
| Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 1,570 | 405 | 0.3% |
| Durata Sts Optim Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 1,494 | 1,784 | 3.9% |
| Quadra Assura Ddqp+ | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,463 | 0 | 2.3% |
| Unify Assura CRT-D RF HV | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,340 | 186 | 3.7% |
| Tendril Sts | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 1,185 | 4,320 | 3.1% |
| Implantable Cardioverter Defibrillator Non-Crt | Implantable cardioverter defibrillator (non-crt) | 868 | 197 | 0.5% |
| Permanent Pacemaker Electrode | Permanent pacemaker electrode | 759 | 332 | 0.4% |
| Fortify Assura VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 742 | 213 | 2.3% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 723 | 38 | 2.4% |
| Quadra Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 700 | 67 | 0.8% |
| Confirm | Recorder, event, implantable cardiac, (without arrhythmia detection) | 650 | 34 | 0.1% |
| Unify Quadra Crt-D Us Model Df4comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 633 | 4 | 5% |
| Quartet | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 608 | 848 | 5.2% |
| 6f Angio-Seal Vascular Closure Device Vip | Device, hemostasis, vascular | 589 | 0 | 4% |
| Swartz Braided Transseptal Guiding Introducer, SL0, 63 cm Length, 8.5 F | Introducer, catheter | 584 | 212 | 1.5% |
| Pulse Generator Permanent Implantable | Pulse generator, permanent, implantable | 532 | 24 | 1.1% |
| Permanent Defibrillator Electrodes | Permanent defibrillator electrodes | 531 | 230 | 0.6% |
| Unify Quadra CRT-D, OUS model, DF4comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 496 | 3 | 1% |
| Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode | Drug eluting permanent left ventricular (lv) pacemaker electrode | 461 | 80 | 0.3% |
| Durata Sts Optim Active Fixation | Implantable cardioverter defibrillator (non-crt) | 434 | 301 | 5.6% |
| Fast-Cath Transseptal Guiding Introducer Swartz SL Transseptal Series, SL1 8. | Introducer, catheter | 432 | 26 | 0.8% |
| Defibrillator Automatic Implantable Cardioverter With Cardiac Resynchronizatio | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 409 | 50 | 1% |
| Advisor HD Grid Mapping Catheter, Sensor Enabled | Catheter, electrode recording, or probe, electrode recording | 405 | 32 | 3.3% |
| Fortify Vr U1 6 Sj4 Us | Pulse generator, permanent, implantable | 405 | 8 | 1.2% |
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 |
|---|---|---|---|
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 15,058 | 24.4% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 8,065 | 13.1% |
| MOM | System, hemodynamic, implantable | 5,736 | 9.3% |
| DYB | Introducer, catheter | 5,505 | 8.9% |
| NVN | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 4,220 | 6.8% |
| NVY | Permanent defibrillator electrodes | 3,414 | 5.5% |
| MGB | Device, hemostasis, vascular | 2,303 | 3.7% |
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | 1,996 | 3.2% |
| DTB | Permanent pacemaker electrode | 1,509 | 2.4% |
| NVZ | Pulse generator, permanent, implantable | 1,288 | 2.1% |
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
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 reports
How many FDA device reports name St Jude Medical as manufacturer?
61,640 reports through August 2026, 74 of them in the latest 12 months.
Which of its brands appear most often?
Unify Crt-D (3,069), HF Sensor Delivery System (2,908), Quadra Assura Crt-D Quad Rf Hv (2,349), Cardiomems Patient Electronic System (2,298) and Unify Assura ICD (1,805).
Which device types does it report on?
defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (24.4%), implantable cardioverter defibrillator (non-crt) (13.1%), system, hemodynamic, implantable (9.3%) and introducer, catheter (8.9%).
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.