N
Patient 1
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER?S INVESTIGATION IS COMPLETED.
MAUDE MDR 9907990
- MDR report key
- 9907990
- Report number
- 2916596-2020-01720
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-14
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. BOB FRYC
- Address
- 6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
- Phone
- 781-781-7818
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) | VENTRICULAR (ASSISST) BYPASS | THORATEC CORPORATION | DSQ | 106015 | 106015 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT HAD A GASTROINTESTINAL (GI) BLEED AND UNDERWENT A PUSH ENTEROSCOPY (N/A). THERE WAS NO BLEEDING OR SOURCE OF ANEMIA IDENTIFIED ON THE ENTEROSCOPY. THE PATIENT ALSO UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD). NO FURTHER INFORMATION WAS AVAILABLE.