Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2011-03-31 | Z-2733-2011 | Terminated | The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM | — | clearance family |
Regulatory clearances
- 510(k)K101968Substantially equivalent (SESE) · 2010-09-15clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-13 | NAI | No action indicated | St. Jude Medical | 0 |
| 2019-03-20 | NAI | No action indicated | St. Jude Medical | 0 |
| 2018-03-20 | NAI | No action indicated | St. Jude Medical | 0 |
| 2016-07-28 | VAI | Voluntary action indicated | St. Jude Medical | 9 |
| 2016-04-11 | NAI | No action indicated | St. Jude Medical | 0 |
| 2015-09-30 | WL | Warning Letter | St. Jude Medical | — |
| 2015-06-26 | OAI | Official action indicated | St. Jude Medical | 12 |
| 2014-07-31 | NAI | No action indicated | St. Jude Medical | 0 |
| 2014-05-06 | NAI | No action indicated | St Jude Medical Inc | 0 |
| 2012-10-03 | NAI | No action indicated | St Jude Medical Inc | 0 |
| 2012-06-05 | WL | Warning Letter | St. Jude Medical | — |
| 2012-02-28 | NAI | No action indicated | St. Jude Medical | 0 |
| 2011-11-30 | OAI | Official action indicated | St. Jude Medical | 3 |
| 2011-06-15 | OAI | Official action indicated | St. Jude Medical | 0 |
| 2011-04-21 | VAI | Voluntary action indicated | St. Jude Medical | 0 |
| 2011-03-21 | NAI | No action indicated | St. Jude Medical | 0 |
| 2011-03-01 | NAI | No action indicated | St. Jude Medical | 0 |
| 2010-09-21 | VAI | Voluntary action indicated | St Jude Medical Inc | 0 |
| 2010-04-19 | NAI | No action indicated | St. Jude Medical | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | St Jude Medical Inc | 5 |
| 2010-01-22 | VAI | Voluntary action indicated | St. Jude Medical | 5 |
| 2009-04-17 | WL | Warning Letter | St. Jude Medical | — |
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