Pacemaker Battery
Cardiovascular · 21 CFR 870.3610
Recent MDR events
14 adverse event reports on file
- CARDINAL HEALTH BATTERYMar 23, 2012InjuryCardinal HealthMW5024814
- PROTOSE DR BIOTRONIK BATTERYNov 12, 2004InjuryBiotronik, Inc.555810
- MEDTRONICSMay 5, 2004InjuryMedtronic Inc.540404
- HIGHRATE PACEMAKER BATTERYJan 31, 1997Medtronic, Inc.MW4001758
- INTERMEDICS, INC.Jan 11, 1995InjuryIntermedics, Inc.21273
- PACEMAKERDec 30, 1994Cardiac Pacemaker Inc.21301
- VERSIPOWER BATTERY MODULEJun 13, 1994OtherZimmer-hall Surgical32768-1994-00012
- MEDTRONIC DUAL CHAMBER PACEMAKERAug 16, 1993InjuryMedtronic6317
- ITRELL GENERATORJun 17, 1993InjuryMedtronic5023
- MEDTRONICApr 28, 1993MalfunctionMedtronic5230
Event type breakdown
Recalls
2 recall events for this product code
- SynCardia Systems Inc.TerminatedDec 28, 2012
Companion External Battery, Part Number: 293001-001
Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.
Z-0620-2013 · View FDA record ↗ - Maquet Cardiovascular, LLCTerminatedJul 22, 2010
Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
Z-2064-2010 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.