NHWClass IILife-sustaining
Electrode, Pacing And Cardioversion, Temporary, Epicardial
Cardiovascular · 21 CFR 870.3680
The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.
MDR events125All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
125 adverse event reports on file
- LEADMar 6, 2023MalfunctionSt. Jude Medical, Inc.(crm-sylmar)2017865-2023-11916
- LVMar 22, 2022MalfunctionSt. Jude Medical, Inc.(crm-sylmar)2017865-2022-05994
- TELIGEN E110Oct 12, 2017InjuryBoston ScientificMW5072718
- POSSISJul 1, 2015InjuryExternal Manufacturer2124215-2015-06455
- GUIDANTOct 30, 2013MalfunctionGreatbatch Medical3516546
- PATCHOct 7, 2013InjuryCpi - Del Caribe2124215-2013-13523
- PATCHOct 7, 2013InjuryCpi - Del Caribe2124215-2013-13528
- UNKNOWNOct 3, 2013MalfunctionGuidant Angleton/st. Paul2124215-2013-13256
- PATCHJul 22, 2013InjuryHistorical Puerto Rico2124215-2013-08455
- PATCHJul 22, 2013InjuryHistorical Puerto Rico2124215-2013-08459
Event type breakdown
Injury91
Malfunction31
Death2
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.