BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3181416 · Received June 14, 2013

    Report

    Report Number
    2916596-2013-00711
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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 RED HEART ALARMS WHILE CONNECTED TO THE PT CABLE. THE PT'S LOG HISTORY SHOWED EVIDENCE OF A POTENTIAL PERCUTANEOUS LEAD FRACTURE, HOWEVER, THE HOSPITAL WAS UNABLE TO REPRODUCE THE ALARMS. THE PT EXCHANGE THE POWER MODULE PT CABLE AND SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270713 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 117494

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention