BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVAS KIT, HM-II, EUROPEAN, EP

    MDR report key: 2172198 · Received June 15, 2011

    Report

    Report Number
    2916596-2011-00239
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS IMPLANTED WITH THE LVAD PUMP. NO FURTHER INFO 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. APPROX 10 MONTHS POST-IMPLANT, THE PT CALLED THE HOSP TO REPORT SEVERAL ALARMS WHILE CONNECTED TO THE POWER BASE UNIT (PBU) AS WELL AS A VIBRATING FEELING AND PUMP STOPPAGES. THE PT WAS ADMITTED TO THE HOSP AND THE PBU, PBU PT CABLE AND SYSTEM CONTROLLER WERE EXCHANGED, BUT THE ALARMS DID NOT RESOLVE. SINCE THE PT EXPERIENCED NO ALARMS WHILE ON BATTERY SUPPORT, HE WAS CONNECTED TO BATTERIES DURING THE NIGHT. THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD HAS BEEN REPLACED BY THE THORATEC TECHNICAL SERVICE TEAM AND THE PT HAS BEEN LISTED FOR TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LVAS KIT, HM-II, EUROPEAN, EP VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other