BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3221436 · Received July 9, 2013

    Report

    Report Number
    2916596-2013-00823
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 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 LVAD'S PERCUTANEOUS LEAD WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED LVAD SPEED REDUCTIONS AND PUMP STOPPAGES WHILE CONNECTED TO THE POWER MODULE. THE LOG FILES INDICATED SYMPTOMS OF PERCUTANEOUS LEAD FAILURE. THE PERCUTANEOUS LEAD WAS BADLY KINKED JUST BEFORE THE DISTAL END BEND RELIEF. THE PERCUTANEOUS LEAD WAS REPLACED. ADD'L INFO INDICATED THAT THE PT REC'D RED HEART ALARMS FROM THE PERCUTANEOUS LEAD, BUT REPLACING THE SYS CONTROLLER RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313604 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105449

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention