FDA Adverse Event
Summary report: N
HEARTMATE II
MDR report key: 3820083
·
Received May 16, 2014
Report
- Report Number
- 3820083
- Date Received
- May 16, 2014
- Date of Event
- January 23, 2014
- Report Date
- May 16, 2014
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT HAD A HEARTMATE II LVAD PLACED ON IN THE FALL OF 2013. APPROXIMATELY 6 WEEKS LATER, THE PATIENT SHOWED SIGNS OF PUMP THROMBOSIS.(VAD EPC) ULTIMATELY THE PUMP NEEDED TO BE REPLACED APPROXIMATELY 10 WEEKS LATER. THIS PUMP WAS SENT BACK TO MANUFACTURER FOR EVALUATION. ABOUT 7 WEEKS LATER THE PATIENT AGAIN SHOWED/ CONFIRMED SIGNS OF THROMBOSIS. LVAD PUMP BODY REPLACED AGAIN. THIS WAS RETURNED TO MANUFACTURER FOR INSPECTION. FOLLOWING THE LAST PUMP REPLACEMENT, THE PATIENT HAD 2 BRIEF PUMP STOPPAGES (LASTING 2 SECONDS WHICH SELF-ABATED). WE COULD NOT IDENTIFY WHY SHE HAD THESE STOPPAGES, AND AS A MEANS OF TROUBLE SHOOTING, THE CONTROLLER WAS REPLACED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294250 | HEARTMATE II | VENTRICULAR (ASSISST) BYPASS | DSQ | THORATEC CORPORATION | * | 135219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |