BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3983353 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01090
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUES REPORTED. A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE EVALUATION CONFIRMED THE REPORTED EVENT. APPROXIMATELY 20 INCHES OF THE EXTERNAL PORTION/DISTAL END OF THE REPLACED PERCUTANEOUS LEAD WAS RETURNED AND THE EVALUATION REVEALED THE YELLOW WIRE WAS FRACTURED AT THE TERMINUS OF THE BEND RELIEF AND AS A RESULT, THE UNDERLYING WIRE CONDUCTORS WERE EXPOSED. THE CHARACTERISTIC OF THE DISRUPTION APPEARED CONSISTENT TO FATIGUE FAILURE AS A RESULT OF REPETITIVE FLEXING OF THE LEAD IN THIS LOCATION AND THERE WAS NO EVIDENCE OF CRUSHING OR PINCHING TO THE LEAD IN THIS AREA. THE REPORTED ALARMS AND PUMP STOPS WOULD HAVE OCCURRED AS A RESULT OF THE EXPOSED CONDUCTORS CONTACTING THE BRAIDED SHIELD AND SHORTING TO GROUND WHILE SUPPORTED BY THE POWER MODULE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE FAULT ALARM WITH A PUMP STOP/RED HEART ALARM WHEN BENDING OVER. THE VAD COORDINATOR INSTRUCTED THE PATIENT TO SWITCH TO THE BACKUP SYSTEM CONTROLLER AND THE DRIVE FAULT ALARM REPORTEDLY RE-OCCURRED. A REVIEW OF THE LOG FILES SUBMITTED TO THE MANUFACTURER FOR ANALYSIS APPEARED CONSISTENT WITH A PERCUTANEOUS LEAD (LEAD) ISSUE. THE X-RAY IMAGES SHOWED AN AREA NEAR THE PUMP AND BEND RELIEF AND ONE AREA A FEW INCHES FROM THE CONTROLLER/LEAD CONNECTION TO BE SUSPECT OF DRIVELINE DAMAGE. THE PATIENT REPORTED CLEARING THE RED HEART ALARM UPON MANIPULATION A SECTION OF THE EXTERNAL LEAD. AN EVALUATION OF THE PATIENT'S PERCUTANEOUS LEAD SCHEDULED BY THE MANUFACTURER REVEALED A BROKEN WIRE CONDUCTOR ON THE LEAD. AN EXTERNAL PERCUTANEOUS LEAD REPLACEMENT WAS SUBSEQUENTLY PERFORMED BY THE MANUFACTURER'S TECHNICAL SERVICES. NO FURTHER ISSUES OR ALARMS WERE REPRODUCED AFTER THE REPAIR/REPLACEMENT WAS COMPLETED. THE PATIENT WAS DISCHARGED HOME AND IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394941 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 119460

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other