N
Patient 1
THE IMPELLA CP PUMP WAS NOT RETURNED BY THE CUSTOMER THEREFORE A FAILURE ANALYSIS INVESTIGATION CANNOT BE COMPLETED. IF DEVICE IS RECEIVED AFTER THIS DATE, AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE FILED.
MAUDE MDR 9845484
- MDR report key
- 9845484
- Report number
- 1220648-2020-00383
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-02
- Date received
- 2020-03-17
- 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
- MR. RALPH BARISANO
- Address
- 22 CHERRY HILL DR. DANVERS MA 01923 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPELLA CP PUMP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, | ABIOMED EUROPE GMBH | OZD | IMPELLA CP PUMP SET EU | 0048-0002 | 1455282 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-17 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE COMPLAINANT REPORTED A (B)(6) OLD WHITE MALE PATIENT HAD IMPELLA CP PUMP INSERTED IN THE LEFT FEMORAL FOR ACUTE MYOCARDIAL INFARCTION (AMI) WITH SHOCK TAKOTSUBO