FDA Adverse Event
Malfunction
Summary report: N
CARDIOMEMS POWER SUPPLY
MDR report key: 23888341
·
Received December 24, 2025
Report
- Report Number
- 3004936110-2025-06637
- Event Type
- Malfunction
- Date Received
- December 24, 2025
- Date of Event
- December 19, 2025
- Report Date
- March 31, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MOM
- PMA / PMN Number
- P100045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ONE POWER SUPPLY AND ONE POWER CORD MODEL WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT.
Additional Manufacturer Narrative · 0
THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
Description of Event or Problem · 0
THE PATIENT REPORTED EXPOSED AND FRAYED WIRES OF THE POWER CORD. THE POWER CORD AND POWER SUPPLY WERE REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2476972 | CARDIOMEMS POWER SUPPLY | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ABBOTT MEDICAL | CM1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female |