BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3221487 · Received July 9, 2013

    Report

    Report Number
    2916596-2013-00879
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER IS CURRENTLY INDEFINITELY QUARANTINED IN THE HOSPITAL'S RISK MANAGEMENT. THE LABELING WARNS THAT THE SYSTEM CONTROLLER SHOULD NOT BE PLACED ON BARE SKIN FOR AN EXTENDED PERIOD OF TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'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'S NURSE THAT THE PATIENT SUFFERED A SKIN BURN DUE TO THE SYSTEM CONTROLLER LYING AGAINST HIS SKIN. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE NEW SYSTEM CONTROLLER WAS ISOLATED SO THAT IT WAS NOT TEST TO THE PATIENT'S SKIN. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313526 HEARTMATE II SYSTEM CONTROLLER DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106762

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention