BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2810006 · Received October 23, 2012

    Report

    Report Number
    2916596-2012-01016
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MFR FOR EVAL. THE PUMP WAS RETURNED WITH THE PERCUTANEOUS LEAD CUT AT THE PUMP END BEND RELIEF AND SEVERED PORTION WAS RETURNED. EXAMINATION OF THE PERCUTANEOUS LEAD FOUND BREAKDOWN TO THE BRAIDED SHIELD AT THE TERMINUS OF THE CONNECTOR BEND RELIEF, AND THE ORANGE AND YELLOW WIRES APPEARED TO BE DAMAGED. ELECTRICAL CONTINUITY TESTING OF THE LEAD FOUND THAT ORANGE WIRE WAS OPEN CIRCUIT AND THE REMAINING WIRES WERE INTACT. VISUAL INSPECTION OF THE WIRES FOUND THAT THE ORANGE WIRE WAS BROKEN AND THE YELLOW WIRE INSULATION WAS BREACHED, AND THE MAJORITY OF THE INNER CONDUCTORS OF THE YELLOW WIRE WERE BROKEN. EXAMINATION OF THE ADJACENT WIRES FOUND TEARS IN THE RED AND BLACK WIRE INSULATION AND THE INNER CONDUCTORS WERE EXPOSED. THE BROWN AND GREEN WIRES APPEARED UNREMARKABLE. IF ANY OF THE EXPOSED CONDUCTORS THE BRAIDED SHIELD WHILE OPERATING ON A TETHERED POWER SOURCE, THE RESULTING SHORT TO GROUND WOULD HAVE RESULTED IN THE REPORTED RED HEART ALARMS AND PUMP STOPPAGES. THE REPORTED EVENT ALSO COULD HAVE RESULTED FROM THE PHASE TO PHASE SHORT IF THE INNER CONDUCTORS OF WIRES FROM TWO DIFFERENT MOTOR PHASES MADE DIRECT CONTACT OR SIMULTANEOUS CONTACT WITH THE BRAIDED SHIELD. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF CYCLIC FLEXING. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PT WAS AT HOME, THE PT'S SPOUSE NOTED THAT THERE WAS NO DATA DISPLAYED ON THE DISPLAY MODULE AND NO ALARMS. THE PT'S WIFE CALLED THE HOSPITAL AND EXCHANGED THE SYSTEM CONTROLLER AND A RED HEART ALARM OCCURRED. THE PT SWITCHED BACK TO THE PRIMARY SYSTEM CONTROLLER AND NO DATA WAS DISPLAYED. THE PT WAS SWITCHED FROM BEING CONNECTED TO THE POWER MODULE TO BATTERY POWER WITHOUT RESOLUTION. THE PT WAS TRANSFERRED TO THE HOSPITAL. A DECISION WAS MADE NOT TO RESTART THE PUMP AS IT HAD BEEN OFF FOR APPROX 4 HOURS HAD TO EXCHANGE THE PT'S PUMP. THE PT'S PUMP WAS EXCHANGED, AND THE PT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 98882

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention