BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3131119 · Received May 23, 2013

    Report

    Report Number
    2916596-2013-00634
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE HOSPITAL BIOMED DEPARTMENT THAT THE PATIENT'S PERCUTANEOUS LEAD DAMAGE WAS CAUSING PUMP STOPPAGE WITH RED HEART ALARMS. ON (B)(4) 2013, THE MFR'S TECHNICAL SERVICES REP PERFORMED A PERCUTANEOUS LEAD DISTAL END REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229595 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104775

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention