BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4873191 · Received June 27, 2015

    Report

    Report Number
    2916596-2015-01167
    Event Type
    Malfunction
    Date Received
    June 27, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 29, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 3 YEARS AND 4 MONTHS. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. THE REPLACED PORTION OF THE DRIVELINE WAS RECEIVED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE SYSTEM CONTROLLER WAS REPORTEDLY DISCARDED BY THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - EVALUATION OF THE PERCUTANEOUS LEAD CONFIRMED DAMAGE TO THE BROWN AND RED WIRES NEAR THE METAL CONNECTOR. AS A RESULT OF THE DAMAGE, THE UNDERLYING BROWN AND RED WIRE CONDUCTORS WERE EXPOSED. THE BROWN WIRE REPRESENTS A REDUNDANT WIRE IN MOTOR PHASE 2. THE RED WIRE REPRESENTS A REDUNDANT WIRE IN MOTOR PHASE 3. THE REPORTED RED HEART ALARMS WOULD HAVE OCCURRED AS A RESULT OF THE EXPOSED CONDUCTORS OF THE WIRES CONTACTING THE BRAIDED SHIELDING WHEN THE DEVICE WAS SUPPORTED BY THE POWER MODULE. FURTHERMORE, A RED HEART ALARM WOULD HAVE OCCURRED ON BATTERY IF THE EXPOSED CONDUCTORS MADE CONTACT WITH EACH OTHER. THE DAMAGE APPEARED TO BE CONSISTENT WITH FATIGUE DAMAGE DUE TO REPETITIVE FLEXING ON THE WIRE AT THIS LOCATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PATIENT REPORTED EXPERIENCING PUMP STOPPAGES WHILE CONNECTED TO THE POWER MODULE. THE PATIENT WENT TO THE HOSPITAL AND NO ALARMS OCCURRED WHILE THE PUMP WAS CONNECTED TO THEIR EQUIPMENT. THE PATIENT WAS GIVEN A NEW PATIENT CABLE AND WAS RELEASED. A COUPLE OF HOURS LATER THE ALARMS AND PUMP STOPPAGES RECURRED AT HOME. THE PATIENT WAS ADMITTED AND AT THE TIME OF ADMISSION THE PUMP WAS REPORTED TO BE OFF. AN ANGIOMAX BOLUS INFUSION WAS STARTED. AN EXPOSED AREA OF THE DRIVELINE WAS NOTED AT THE METAL CONNECTOR. THE ALARMS AND PUMP STOPPAGES WERE ABLE TO BE REPRODUCED BY TAPPING THE DRIVELINE. THE DRIVELINE WAS DISCONNECTED AND RECONNECTED TO THE PATIENT'S SYSTEM CONTROLLER WHICH VIBRATED, BUT DID NOT START THE PUMP. THE PUMP WAS THEN CONNECTED TO THE BACKUP SYSTEM CONTROLLER AND IT RESTARTED WITHOUT ISSUE. IT WAS UNCLEAR HOW MANY MINUTES THE PUMP WAS OFF. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE COURSE OF THE EVENT. THE PUMP PARAMETERS WERE WITHIN NORMAL LIMITS AFTER THE PUMP RESTARTED. ON (B)(6) 2015 THE MANUFACTURER'S TECHNICAL SERVICES PERFORMED A CONTINUITY TEST AND NO BROKEN WIRES WERE FOUND. A DISTAL END DRIVELINE REPLACEMENT WAS COMPLETED. NO ISSUES WERE NOTED AFTER THE PATIENT WAS PLACED ON A GROUNDED POWER MODULE PATIENT CABLE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417004 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR SYSTEM CONTROLLER: SERIAL NUMBER UNKNOWN