BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2190673 · Received August 4, 2011

    Report

    Report Number
    2190673
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 21, 2011
    Report Date
    October 18, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DRIVE UNIT FAILUREADDITIONAL TEXT: POSS. PERK LEAD FRACTURESPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTIONADDITIONAL TEXT: POSS. PERK LEAD FRACTUREOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTIONOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF DRIVELINE; REPLACEMENT OF PUMPOTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DRIVE UNIT FAILURE. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47.4 YR