BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3011142 · Received March 15, 2013

    Report

    Report Number
    2916596-2013-00255
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED BASED ON EVALUATION OF THE RETURNED PUMP. EXAMINATION OF THE PERCUTANEOUS LEAD REVEALED THE INSULATION OF THE GREEN WIRE WAS DISRUPTED AND THE UNDERLYING CONDUCTORS WERE EXPOSED AT THE TERMINUS OF THE EXTERNAL BEND RELIEF. THE DISRUPTION OF THIS WIRE APPEARED TO BE CONSISTENT WITH FATIGUE AS A RESULT OF REPETITIVE FLEXING. THE GREEN WIRE REPRESENTS ONE OF THE TWO WIRES IN MOTOR PHASE 1. IF THE EXPOSED CONDUCTORS OF THIS WIRE CONTACTED THE BRAIDED SHIELD WHILE THE PUMP WAS OPERATING ON POWER MODULE, THE RESULTING SHORT TO GROUND WOULD HAVE RESULTED IN THE REPORTED EVENT. TWO SYSTEM CONTROLLERS WERE ALSO RETURNED ASSOCIATED WITH THIS EVENT. EVALUATION AND EVENTS RECORDED IN THE LOG FILES ALSO CONFIRMED THE REPORTED EVENT AND WERE CONSISTENT WITH THE PUMP EVALUATION FINDINGS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT PRESENTED TO THE ER AFTER LOSING CONSCIOUSNESS IN THE EARLY MORNING HOURS OF (B)(6) 2013. THE PT'S CARE GIVER HEARD A THUMP FOLLOWED BY AN ALARM. THE CARE GIVER WENT TO INVESTIGATE AND FOUND THE PT ON THE FLOOR WITH THE RED HEART ALARM ON THE SYSTEM CONTROLLER. THE CARE GIVER REPORTED THAT A MESSAGE ON THE SYSTEM CONTROLLER INDICATED THAT THE PUMP HAD BEEN STOPPED FOR APPROXIMATELY 8 MINUTES. THE PT WAS SWITCHED TO THE BACK UP. SYSTEM CONTROLLER AND REGAINED CONSCIOUSNESS. ON (B)(6) 2013, X-RAYS WERE DONE TO ASSESS FOR PERCUTANEOUS LEAD FRACTURE. THE SURGEON COMMENTED THAT HE COULD NOT APPRECIATE ANY OBVIOUS BREAKS. AFTER ANOTHER INCIDENT AND RED HEART ALARM, THE SURGEON DECIDED TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110490 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 91898

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention