FDA Adverse Event
Malfunction
Summary report: N
CARDIOMEMS¿ HOSPITAL SYSTEM
MDR report key: 20634327
·
Received November 7, 2024
Report
- Report Number
- 3004936110-2024-01665
- Event Type
- Malfunction
- Date Received
- November 7, 2024
- Date of Event
- September 30, 2024
- Report Date
- November 7, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC. - CARDIOMEMS
- Product Code
- MOM
- UDI-DI
- 05415067034724
- PMA / PMN Number
- P100045
- Removal / Correction Number
- FA-Q424-HF-3
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CAPA 138841 HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE.
Description of Event or Problem · 0
THE DEVICE IS INCLUDED IN THE FA-Q424-HF-3 HEART FAILURE CLOUD FMR MIGRATION ¿ HOSPITAL SYSTEM (CM3100) UNABLE TO SEND READINGS INITIATED ON 21OCT2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2043977 | CARDIOMEMS¿ HOSPITAL SYSTEM | System, hemodynamic, implantable | MOM | ST. JUDE MEDICAL, INC. - CARDIOMEMS | CM3100 | 8394740 | 05415067034724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |