FDA Adverse Event Malfunction Summary report: N

HEARTMATE II SYSTEM CONTROLLER

MDR report key: 2904038 · Received January 3, 2013

Report

Report Number: 2916596-2012-01289
Event Type: Malfunction
Date Received: January 3, 2013
Date of Event: November 16, 2012
Report Date: December 5, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR ANALYSIS AND THE REPORT THAT THE PT WAS EXPERIENCING LOW VOLTAGE ADVISORY ALARMS DESPITE USING FULLY CHARGED BATTERIES WAS CONFIRMED. THE EVAL OF THE RETURNED SYSTEM CONTROLLER REVEALED BROKEN WIRES IN THE BLACK POWER LEAD UNDER THE STRAIN RELIEF AT THE HOUSING SIDE. MOVEMENT OF THE BLACK POWER LEAD DURING TESTING RESULTED IN LOW VOLTAGE ALARMS AS WELL AS INTERRUPTION OF PUMP FUNCTION. ALTHOUGH, THE BLACK STRAIN RELIEF WAS NOT DAMAGED, THE ROOT CAUSE FOR THE BROKEN WIRES APPEARED TO BE RELATED TO FATIGUE DUE TO REPETITIVE LEAD FLEXING IN THAT AREA DURING CLINICAL USE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATION. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

Description of Event or Problem · 1

THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING LOW VOLTAGE ADVISORY ALARMS DESPITE USING FULLY CHARGED BATTERIES. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED AS PER THE INSTRUCTIONS IN THE INFORMATION FOR USE (IFU) AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
3624	HEARTMATE II SYSTEM CONTROLLER	LVAD SYSTEM CONTROLLER	DSQ	THORATEC CORP.	103696

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Other