BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2770336 · Received October 1, 2012

    Report

    Report Number
    2916596-2012-00916
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF SPEED DROPS AND PUMPS STOPPAGES WAS CONFIRMED BASED ON THE EVALUATION OF THE REPLACED SECTION OF THE PERCUTANEOUS LEAD. A SECTION OF THE PERCUTANEOUS LEAD APPROX 19" LONG WAS RETURNED FOR EVALUATION. EXAMINATION OF THE LEAD FOUND THAT THE MAJORITY OF THE BRAIDED SHIELD SHOWED BREAKDOWN AND HAD FALLEN APART. ELECTRICAL CONTINUITY TESTING OF THE LEAD DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. VISUAL INSPECTION OF THE WIRES FOUNDED BREACHES IN THE RED AND BROWN WIRES APPROX 13.5" FROM THE METAL CONNECTOR. EXAMINATION OF THE ADJACENT WIRES FOUND SOME ABRASIONS, BUT THE INNER CONDUCTORS WERE NOT EXPOSED. THE EXAMINATION ALSO FOUND A SMALL BREACH IN THE BLACK WIRE ADJACENT TO THE METAL CONNECTOR. IF ANY OF THE EXPOSED CONDUCTORS CONTACTED 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 THE RED WIRE AND EITHER THE BLACK OR BROWN WIRE MADE DIRECT CONTACT OR SIMULTANEOUS CONTACT WITH THE BRAIDED SHIELD. THE OBSERVED TEARS APPEARED TO BE THE RESULT OF CYCLIC FLEXING. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING LOW SPEED AND PUMP STOP EVENTS WHEN CONNECTED TO THE PT CABLE. THE PT WAS ADMITTED. A PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 73664

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention