HF SENSOR DELIVERY SYSTEM
Report
- Report Number
- 3004936110-2025-06206
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 8, 2025
- Report Date
- November 3, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MOM
- UDI-DI
- 05414734509237
- PMA / PMN Number
- P100045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DHR WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. PER THE IFU, RIGHT HEART CATHETERIZATION IS REQUIRED FOR SYSTEM BASELINE (MEAN PRESSURE) CALIBRATION AND MAY BE NEEDED TO RECALIBRATE THE BASELINE (MEAN PRESSURE) IN ORDER TO CONTINUE TO USE THE SYSTEM.
THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
ADDITIONAL INFORMATION WAS PROVIDED ON OCTOBER 7, 2025, CONFIRMING THAT THE RIGHT HEART CATHETERIZATION PROCEDURE WAS NOT PERFORMED PRIMARILY TO CHECK THE CARDIOMEMS PRESSURES BUT WAS BEING PERFORMED AS A ROUTINE CARE FOR THIS PATIENT.
A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS DECREASED BY 5 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2733423 | HF SENSOR DELIVERY SYSTEM | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ABBOTT MEDICAL | CM2000 | 7963314 | 05414734509237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |