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