FDA Adverse Event
Injury
Summary report: N
EXTERNAL PACEMAKERS
MDR report key: 23742639
·
Received December 8, 2025
Report
- Report Number
- MW5180100
- Event Type
- Injury
- Date Received
- December 8, 2025
- Report Date
- December 3, 2025
- Manufacturer
- BIOTRONIK, INC.
- Product Code
- OVJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
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, MW5180097, MW5180098, MW5180099.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2796520 | EXTERNAL PACEMAKERS | PULSE GENERATOR, EXTERNAL PACEMAKER, DUAL CHAMBER | OVJ | BIOTRONIK, INC. | REOCOR S, REOCOR D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |