BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE GO GEAR BELT

    MDR report key: 3161787 · Received June 6, 2013

    Report

    Report Number
    2916596-2013-00669
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE PRODUCT FOR FURTHER EVAL. NO FURTHER INFORMATION 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 USED THE MODULAR BELT TO CARRY HER EQUIPMENT AND WHEN SHE BENT OVER THE SYSTEM CONTROLLER SLID OUT OF THE BELT AND PULLED ON THE PUMP'S PERCUTANEOUS LEAD CAUSING DAMAGE TO THE PERCUTANEOUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251659 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE GO GEAR BELT DSQ: MODULAR BELT DSQ THORATEC CORP. 104227

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention