Device manufacturer, as written on reports
St Jude Medical Crm-Kista: medical device reports filed with FDA
5,323 reports name it as the manufacturer of the device involved, 2015–2016.
- 5,323
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 50.1%
- classified as malfunction
- 62.3% across all reports
- 1.6%
- classified as death, as reported
- 0.9% across all reports
5,323 medical device reports received by FDA give St Jude Medical Crm-Kista as the manufacturer of the device involved, 0% of the MAUDE database, from April 2015 to July 2016. 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 malfunction (50.1%), injury (48.3%) and death (1.6%). 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 |
|---|---|---|---|---|
| Durata Sts Optim Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 637 | 1,784 | 3.9% |
| Tendril Sts | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 344 | 4,320 | 3.1% |
| Quartet | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 287 | 848 | 5.2% |
| Durata Sts Optim Active Fixation | Implantable cardioverter defibrillator (non-crt) | 258 | 301 | 5.6% |
| Quadra Assura MP ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 215 | 507 | 2.1% |
| Riata Passive Fixation | Permanent defibrillator electrodes | 192 | 32 | 1.2% |
| Tendril St | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 192 | 547 | 5.2% |
| Riata Active Fixation | Permanent defibrillator electrodes | 185 | 96 | 1.8% |
| Isoflex Optim Lead | Permanent defibrillator electrodes | 147 | 437 | 2% |
| Unify Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 139 | 127 | 1.6% |
| Quickflex Micro Lv Lead | Drug eluting permanent left ventricular (lv) pacemaker electrode | 119 | 116 | 5.9% |
| Optisense Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 113 | 143 | 4.8% |
| Riata St Active Fixation | Permanent defibrillator electrodes | 102 | 76 | 2.2% |
| Quadra Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 89 | 67 | 0.8% |
| Confirm | Recorder, event, implantable cardiac, (without arrhythmia detection) | 82 | 34 | 0.1% |
| Optisure Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 72 | 623 | 4.3% |
| Ellipse VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 68 | 170 | 1.5% |
| Durata Sts Optim Passive Fixation Df-4 Connector | Permanent defibrillator electrodes | 60 | 36 | 2.1% |
| Fortify Vr U1 6 Sj4 Id | Implantable cardioverter defibrillator (non-crt) | 50 | 0 | 0.7% |
| Durata Sts Optim Passive Fixation | Permanent defibrillator electrodes | 48 | 7 | 1.6% |
| Isoflex S Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 41 | 64 | 4.4% |
| Unify Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 38 | 10 | 3.4% |
| Quadra Assura Ddqp+ | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 34 | 0 | 2.3% |
| Fortify Assura VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 29 | 213 | 2.3% |
| Promote Rf Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 15 | 0 | 7.9% |
| Riata St Passive Fixation | Permanent defibrillator electrodes | 15 | 23 | 1.4% |
| Unify Quadra CRT-D, OUS model, DF4comp | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 14 | 3 | 1% |
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
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-Kista reports
How many FDA device reports name St Jude Medical Crm-Kista as manufacturer?
5,323 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
Durata Sts Optim Active Fixation Df-4 Connector (637), Tendril Sts (344), Quartet (287), Durata Sts Optim Active Fixation (258) and Quadra Assura MP ICD (215).
Which device types does it report on?
permanent defibrillator electrodes (31.2%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (17.2%), implantable cardioverter defibrillator (non-crt) (15.5%) and defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (15%).
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.