BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2171445 · Received June 30, 2011

    Report

    Report Number
    2916596-2011-00269
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 CHIEF PERFUSIONIST THAT THE PATIENT HAD EXPERIENCED PUMP STOPS AND UNKNOWN ALARMS WHICH OCCURRED WHEN CONNECTED TO BATTERIES AND SEEMED TO BE DOING FINE WHEN CONNECTED TO THE POWER BASE UNIT. DUE TO CONCERNS OF PERCUTANEOUS LEAD ISSUES, THE PATIENT WAS ADMITTED INTO THE HOSPITAL. INSPECTION OF THE PERCUTANEOUS LEAD AS WELL AS X-RAYS WAS REQUESTED FOR EVALUATION. IN ADDITION, INSPECTION OF THE PATIENT'S BATTERIES AND THE LOG FILES WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 82515

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention