BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3200433 · Received July 1, 2013

    Report

    Report Number
    3200433
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    January 3, 2012
    Report Date
    June 19, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. C/O HM ALARM PROGRESSING FROM OCCASIONAL WITH BENDING TO EVERY TIME SHE MOVES. UNKNOWN WHEN THIS STARTED. RPMS SLOW DOWN WITH ALARM. DEVICE INTERROGATED WAVEFORMS SENT TO THORATEC. WAS DETERMINED, THERE WAS PROBABLY A DRIVELINE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299124 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1