FDA Adverse Event
Injury
Summary report: N
HEARTMATE II LVAS
MDR report key: 2899689
·
Received January 7, 2013
Report
- Report Number
- 2899689
- Event Type
- Injury
- Date Received
- January 7, 2013
- Date of Event
- October 29, 2012
- Report Date
- January 7, 2013
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT REMOVED PM INTERNAL BATTERY WHILE PLUGGED INTO WALL TO PRESERVE CHARGE. THEN REINSERTED BATTERY BACK INTO PM RECEIVED YELLOW WRENCH,RED BATTERY AND AUDIBLE ALARM. THORATEC CORP. SAID TO REPLACE EMERGENCY BATTERY WHILE PM UNPLUGGED. NO FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7151 | HEARTMATE II LVAS | LVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |