FDA Adverse Event Injury Summary report: N

HEARTMATE POWER MODULE

MDR report key: 2924893 · Received January 17, 2013

Report

Report Number: 2916596-2013-00078
Event Type: Injury
Date Received: January 17, 2013
Date of Event: December 21, 2012
Report Date: December 22, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUES. THE POWER MODULE WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

Description of Event or Problem · 1

THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS FOUND DOWN/UNRESPONSIVE BY FAMILY. AT THE TIME THE PATIENT WAS FOUND, AUDIBLE ALARMS WERE HEARD FROM THE SYSTEM CONTROLLER. THE POWER LEADS WERE CONNECTED TO THE PATIENT (SYSTEM CONTROLLER-TO-POWER MODULE PATIENT CABLE CONNECTION) BUT THE POWER MODULE PATIENT CABLE WAS NOT CONNECTED TO THE POWER SOURCE (POWER MODULE). THE POWER MODULE WAS CONNECTED TO THE WALL (AC POWER). THE FAMILY MEMBER CONNECTED THE PATIENT TO BATTERY POWER AND THE ALARMS REPORTEDLY CEASED. THE PATIENT BEGAN BREATHING BUT WAS NOT RESPONSIVE AND WAS TAKEN TO THE HOSPITAL BY EMERGENCY MEDICAL SERVICES (EMS). UPON ARRIVAL IN THE HOSPITAL, THE PATIENT WAS PLACED ON HOSPITAL EQUIPMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26280	HEARTMATE POWER MODULE	LVAD POWER MODULE	DSQ	THORATEC CORP.	1340	106679

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention