BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1990677 · Received February 8, 2011

    Report

    Report Number
    2916596-2011-00064
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT'S PUMP WAS STOPPING EVERY TIME THE PT BENT OVER WHILE ON EITHER BATTERY OR POWER MODULE POWER. THE EXTERNAL MANIPULATION OF THE PERCUTANEOUS LEAD DID NOT INDUCE THE ALARMS. THE LOG FILE INDICATES THE PUMP IS NO LONGER ABLE TO REACH THE SET SPEED. THE FOLLOWING DAY, A DECISION WAS MADE TO EXCHANGE THE LVAD FOR ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 91970

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention