EXTERNAL PACEMAKERS
Received Dec 8, 2025
Report MW5180097 · MDR key 23742332
Device
Generic name
Pulse Generator, External Pacemaker, Dual Chamber
Manufacturer
Biotronik, Inc.Model number
REOCOR S, REOCOR DProduct problems
- No Device Output
- Therapeutic or Diagnostic Output Failure
- No Device Output
- Therapeutic or Diagnostic Output Failure
Patient
NA · Unknown
- Cardiac Arrest
- Cardiac Arrest
Narrative
Description of Event or Problem
THE EXTERNAL PACEMAKER DEVICE, SPECIFICALLY THE REOCOR (MANUFACTURER: BIOTRONIK; MODELS: REOCOR S, REOCOR D), UNEXPECTEDLY CEASED OPERATION DURING THE BATTERY REPLACEMENT PROCESS, LEADING TO THE PATIENT EXPERIENCING CARDIAC ARREST. THE ORIGINAL MANUFACTURER'S MANUAL STATED THAT THERE IS A 30-SECOND WINDOW (DURING WHICH THE CIRCUIT BOARD MAINTAINS POWER/IS SUPPORTED BY RESIDUAL POWER) FOR BATTERY REPLACEMENT. HOWEVER, SEVEN UNITS OF THE EQUIPMENT ARE CURRENTLY IN A FAILURE/INOPERATIVE STATE. PT CODE: 1762. DEVICE CODES: 1435, 3023. REF REPORTS: MW5180093, MW5180094, MW5180095, MW5180096, MW5180098, MW5180099, MW5180100.