N
Patient 1
THE DEVICE IS INCLUDED IN THE ERROR 5 ADVISORY NOTICE ISSUED BY ABBOTT ON 01 JUNE 2018. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
MAUDE MDR 9903297
- MDR report key
- 9903297
- Report number
- 3004936110-2020-00161
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-30
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- STEPHANIE O' SULLIVAN
- Address
- 5050 NATHAN LANE N PLYMOUTH MN 55442 US
- Phone
- 651-651-6517
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CARDIOMEMS PATIENT ELECTRONIC SYSTEM | SYSTEM, HEMODYNAMIC, IMPLANTABLE | ST. JUDE MEDICAL, INC. | MOM | CM1100 | CM1100 | 7189074 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE.