Device manufacturer, as written on reports
St Jude Medical Crm-Sylmar: medical device reports filed with FDA
193,385 reports name it as the manufacturer of the device involved, 2015–2026.
- 193,385
- reports naming it as manufacturer
- 0.7% of all MAUDE reports
- 11,838
- reports, 12 months to August 2026
- 22,220 in the 12 months before
- 48.3%
- classified as malfunction
- 62.3% across all reports
- 2.7%
- classified as death, as reported
- 0.9% across all reports
193,385 medical device reports received by FDA give St Jude Medical Crm-Sylmar as the manufacturer of the device involved, 0.7% of the MAUDE database, from April 2015 to April 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
11,838 reports arrived in the 12 months to August 2026, down 47% from 22,220 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 (49%), malfunction (48.3%) and death (2.7%). 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 Sts | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 36,332 | 4,320 | 3.1% |
| Assurity Mri | Implantable pulse generator, pacemaker (non-crt) | 12,483 | 2,035 | 1.8% |
| Durata Sts Optim Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 11,775 | 1,784 | 3.9% |
| Tendril St | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 9,388 | 547 | 5.2% |
| Quartet | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 8,132 | 848 | 5.2% |
| Quadra Assura MP ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 7,959 | 507 | 2.1% |
| Tendril Sdx Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 7,648 | 431 | 4.5% |
| Gallant HF | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 6,463 | 1,918 | 0.7% |
| Tendril Mri | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 5,393 | 422 | 4.1% |
| Optisure Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 4,206 | 623 | 4.3% |
| Isoflex Optim Lead | Permanent defibrillator electrodes | 4,069 | 437 | 2% |
| Confirm | Recorder, event, implantable cardiac, (without arrhythmia detection) | 3,759 | 34 | 0.1% |
| Unify Assura CRT-D RF HV | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 3,286 | 186 | 3.7% |
| Durata Sts Optim Active Fixation | Implantable cardioverter defibrillator (non-crt) | 2,653 | 301 | 5.6% |
| Fortify Assura VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 2,639 | 213 | 2.3% |
| Quadra Assura Crt-D Quad Rf Hv | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 2,387 | 14 | 2.5% |
| Aveir Leadless Pacemaker, Right Ventricle | Leadless pacemaker | 2,091 | 1,372 | 3.9% |
| Riata Active Fixation | Permanent defibrillator electrodes | 2,030 | 96 | 1.8% |
| Assert-IQ ICM | Recorder, event, implantable cardiac, (without arrhythmia detection) | 1,560 | 1,162 | 0% |
| Optisense Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 1,369 | 143 | 4.8% |
| Aveir Leadless Pacemaker, Right Atrium | Leadless pacemaker | 1,038 | 523 | 1.4% |
| Quickflex Micro Lv Lead | Drug eluting permanent left ventricular (lv) pacemaker electrode | 1,030 | 116 | 5.9% |
| Quartet Lead Small-S, 86 cm | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 933 | 159 | 2.1% |
| Tendril Dx | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 804 | 69 | 2% |
| Merlin Programmer | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 771 | 26 | 0.1% |
| UltiPace Lead, 52cm MRI | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 711 | 673 | 1.8% |
| Gallant VR | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 658 | 245 | 2% |
| Jot Dx ICM | Recorder, event, implantable cardiac, (without arrhythmia detection) | 647 | 139 | 0.1% |
| Quadra Allure MP CRT-P | Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) | 632 | 205 | 2.2% |
| Riata St Active Fixation | Permanent defibrillator electrodes | 607 | 76 | 2.2% |
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 |
|---|---|---|---|
| NVN | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 66,552 | 34.4% |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 34,211 | 17.7% |
| NVY | Permanent defibrillator electrodes | 23,804 | 12.3% |
| LWP | Implantable pulse generator, pacemaker (non-crt) | 20,564 | 10.6% |
| NVZ | Pulse generator, permanent, implantable | 16,044 | 8.3% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 9,912 | 5.1% |
| MXC | Recorder, event, implantable cardiac, (without arrhythmia detection) | 6,309 | 3.3% |
| OJX | Drug eluting permanent left ventricular (lv) pacemaker electrode | 5,848 | 3% |
| PNJ | Leadless pacemaker | 3,872 | 2% |
| DXY | Implantable pacemaker pulse-generator | 2,660 | 1.4% |
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
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 Crm-Sylmar reports
How many FDA device reports name St Jude Medical Crm-Sylmar as manufacturer?
193,385 reports through August 2026, 11,838 of them in the latest 12 months.
Which of its brands appear most often?
Tendril Sts (36,332), Assurity Mri (12,483), Durata Sts Optim Active Fixation Df-4 Connector (11,775), Tendril St (9,388) and Quartet (8,132).
Which device types does it report on?
drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (34.4%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (17.7%), permanent defibrillator electrodes (12.3%) and implantable pulse generator, pacemaker (non-crt) (10.6%).
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.