FDA Adverse Event
Malfunction
Summary report: N
CARDIOMEMS POWER SUPPLY
MDR report key: 24313501
·
Received February 11, 2026
Report
- Report Number
- 3004936110-2026-00270
- Event Type
- Malfunction
- Date Received
- February 11, 2026
- Date of Event
- November 25, 2025
- Report Date
- February 11, 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
Narratives
Additional Manufacturer Narrative · 0
ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM POWER SUPPLY WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. THE BACKPLATE OF THE DEVICE WAS REMOVED AND A STANDARD POWER SUPPLY WAS CONNECTED TO THE UNIT. THE UNIT WAS POWERED ON WITH NO ISSUES OBSERVED. 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.
Description of Event or Problem · 0
THE INVESTIGATION OF THE DEVICE REVEALED A FINDING OF FRAYED AND EXPOSED WIRES ON THE POWER SUPPLY OF THE DEVICE. ADDITIONAL FINDING OF A FRAYED POWER EXTENSION CABLE WAS REPORTED IN MDR-2025-053548-01.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377539 | CARDIOMEMS POWER SUPPLY | System, hemodynamic, implantable | MOM | ABBOTT MEDICAL | CM1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female |