FDA Adverse Event
Malfunction
Summary report: N
CARDIOMEMS POWER SUPPLY
MDR report key: 23568247
·
Received November 17, 2025
Report
- Report Number
- 3004936110-2025-06425
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- November 12, 2025
- Report Date
- March 11, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MOM
- PMA / PMN Number
- P100045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ONE POWER SUPPLY MODEL CM1110 AND ONE POWER CORD MODEL CM3020 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. VISUAL EVALUATION REVEALED NO DAMAGE TO THE POWER CORD. A STANDARD POWER SUPPLY WAS CONNECTED TO A STANDARD UNIT AND THE POWER CORD FUNCTIONED AS INTENDED.
Description of Event or Problem · 0
THE PATIENT REPORTED FRAYED WIRES OF THE POWER CORD. THE POWER CORD AND SUPPLY WERE REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289318 | CARDIOMEMS POWER SUPPLY | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ABBOTT MEDICAL | CM1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |