BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3111288 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00484
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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 PERCUTANEOUS LEAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT EXPERIENCED RED HEART ALARMS AND THE HISTORY SCREEN SHOWED MOTOR STOPPED EVENTS. THERE WAS ALSO A PERCUTANEOUS LEAD SEPARATION AT THE DISTAL END BEND RELIEF. FURTHER EVALUATION FOUND A SMALL CUT IN THE BIONATE JACKET OF PERCUTANEOUS LEAD NEAR DISTAL END BEND RELIEF. A PERCUTANEOUS LEAD REPAIR WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204991 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115863

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention