BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2861607 · Received November 28, 2012

    Report

    Report Number
    2916596-2012-01162
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS STILL IN USE SUPPORTING THE PT; HOWEVER, THE REPLACED PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED EVENT OF RED HEART ALARMS AND PUMP STOPPAGE WAS CONFIRMED. APPROX 8.5" OF THE EXTERNAL PORTION (DISTAL END) OF THE PERCUTANEOUS LEAD WAS RETURNED. EXAMINATION OF THE LEAD REVEALED THAT THE BROWN WIRE WAS FRACTURED AT THE TERMINUS OF THE BEND RELIEF. THE CHARACTERISTIC OF THIS DISRUPTION APPEARED CONSISTENT WITH FATIGUE FAILURE AS A RESULT OF REPETITIVE FLEXING. THE EXAMINATION OF THE AFFECTED AND NON-AFFECTED WIRES DID NOT REVEAL ANY EVIDENCE OF MECHANICAL DAMAGE DUE TO CRUSHING OR PINCHING. THE BROWN WIRE REPRESENTS ONE OF THE TWO WIRES IN MOTOR PHASE 2. THE DISRUPTION OF THIS WIRE WOULD HAVE POTENTIALLY INTERRUPTED PUMP FUNCTION AS A RESULT OF THE EXPOSED CONDUCTORS OF THE WIRE CONTACTING THE SHIELD AND SHORTING TO GROUND WHILE SUPPORTED BY THE POWER MODULE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. 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 THE PT EXPERIENCED RED HEART ALARMS WHILE AT HOME. THE PT'S SYSTEM CONTROLLER AND POWER MODULE PT CABLE WERE EXCHANGED. IT WAS REPORTED THAT THE ALARMS WERE OCCURRING WHEN THE PT WAS CONNECTED TO THE POWER MODULE, BUT NOT ON BATTERY POWER. THE PT WENT TO THE HOSPITAL AND THE VAD COORDINATOR CONNECTED THE WHITE POWER LEAD OF THE SYSTEM CONTROLLER TO THE POWER MODULE AND PUMP STOPS OCCURRED. A KINK IN THE PERCUTANEOUS LEAD AND A TEAR IN THE LEAD JACKET WERE NOTED NEAR THE CONTROLLER CONNECTOR END OF THE DRIVELINE. THE PERCUTANEOUS LEAD WAS EVALUATED AND A DECISION WAS MADE TO REPLACE THE DISTAL END OF PERCUTANEOUS LEAD. THE MFR'S TECHNICAL SUPPORT REP REPLACED THE DISTAL END OF THE PERCUTANEOUS LEAD. THE PT REMAINS ONGOING WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 100931

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention