OVJClass IILife-sustaining
Pulse Generator, External Pacemaker, Dual Chamber
Cardiovascular · 21 CFR 870.3600
A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.
MDR events65All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances0All time
Recent MDR events
65 adverse event reports on file
- REOCOR DJul 9, 2026MalfunctionBiotronik Se & Co. Kg1028232-2026-03259
- REOCOR DJan 9, 2026MalfunctionBiotronik Se & Co. Kg1028232-2026-00111
- REOCOR DJan 9, 2026MalfunctionBiotronik Se & Co. Kg1028232-2026-00110
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180093
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180094
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180095
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180096
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180097
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180098
- EXTERNAL PACEMAKERSDec 8, 2025InjuryBiotronik, Inc.MW5180099
Event type breakdown
Malfunction43
Injury20
Death2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.