FDA Adverse Event Death Summary report: N

HEARTMATE II LVAD

MDR report key: 2921598 · Received January 15, 2013

Report

Report Number: 2916596-2013-00044
Event Type: Death
Date Received: January 15, 2013
Date of Event: December 17, 2012
Report Date: December 17, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN CONSCIOUS IN THE EVENING AS THE PATIENT WAS PREPARING FOR SLEEP. THE FOLLOWING MORNING THE HOME HEALTH SERVICE ARRIVED AND THE PATIENT APPEARED TO HAVE NO SIGNS OF LIFE. THE PT WAS PLUGGED BACK IN AND EMERGENCY SERVICE WAS CALLED. NO MOVEMENT OF FLOW ON ECHO WAS SEEN IN THE EMERGENCY DEPARTMENT. THE PUMP WAS RESTARTED WITH A NORMAL FLOW AND POWER, HOWEVER, THE PATIENT EXPIRED. THE VAD COORDINATOR REQUESTED THAT THE PATIENT¿S WAVEFORMS BE REVIEWED BY THE MFR. UPON REVIEW, THE LOG INDICATED THAT THE PATIENT WAS ON BATTERIES FOR APPROX. 11 HOURS AND 33 MINUTES AT WHICH TIME THE LOW ADVISORY ALARM WAS ACTIVATED. APPROXIMATELY 45 MINUTES LATER, THE LOW BATTERY HAZARD ALARM SOUNDED AND THE SYSTEM CONTROLLER WENT INTO POWER SAVER MODE. THERE WAS A CLOCK RESET AFTER THE LAST ENTRY INDICATING THAT THE SYSTEM CONTROLLER LOST ALL POWER AND WAS RECONNECTED TO POWER AGAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
22703	HEARTMATE II LVAD	DSQ: LEFT VENTRICULAR ASSIST DEVICE	DSQ	THORATEC CORP.	104911	11114

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Death