BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2503215 · Received March 20, 2012

    Report

    Report Number
    2916596-2012-00059
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    December 19, 2011
    Report Date
    February 22, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A LOW VOLTAGE ALARM WAS CONFIRMED DURING ANALYSIS. THE EVALUATION OF THE RETURNED SYSTEM CONTROLLER REVEALED COMPROMISED/BROKEN BROWN AND RED/WHITE INNER WIRES IN THE WHITE POWER LEAD. MOVEMENT OF THE WHITE POWER LEAD AT THE CONNECTOR END RESULTED IN LOW BATTERY AND POWER CABLE DISCONNECT ALARMS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT EXPERIENCED LOW VOLTAGE ALARMS WHILE CONNECTED TO BATTERIES. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 93293

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other