BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3030320 · Received March 28, 2013

    Report

    Report Number
    2916596-2013-00334
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE ADN 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED PUMP STOPPAGE. A REVIEW OF THE LOG FILE CONFIRMED PUMP STOPPAGE. ON (B)(6) 2013 THE MFR'S TECHNICAL SVS REP PERFORMED A PERCUTANEOUS LEAD EVALUATION ON SITE WHICH DID NOT REPRODUCE ANY PUMP STOPPAGE. THE PERCUTANEOUS LEAD PASSED CONTINUITY AND PHASE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129693 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111116

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR