BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HM II LVAS EUROPE

    MDR report key: 2220301 · Received August 16, 2011

    Report

    Report Number
    2916596-2011-00338
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP WITH NO FURTHER ISSUES REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFO 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. APPROXIMATELY 2 YEARS POST-IMPLANT, THE PT REPORTED RED HEART ALARMS. A REVIEW OF THE SYSTEM CONTROLLER LOG FILE REVEALED DECREASES IN PUMP SPEED. AN EXCHANGE OF THE SYSTEM CONTROLLER DID NOT RESOLVE THE ALARMS. THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD WAS INSPECTED AND NO ABNORMALITIES WERE FOUND. X-RAYS WERE TAKEN AND DAMAGE TO THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD WAS SUSPECTED. THREE DAYS LATER, A DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 102139 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention