BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 741395 · Received July 5, 2005

    Report

    Report Number
    2182207-2005-01002
    Event Type
    Malfunction
    Date Received
    July 5, 2005
    Report Date
    June 23, 2005
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIV
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAS RECENTLY EXPERIENCED A LOSS OF EFFICACY DESPITE INCREASE IN DAILY DOSE. AT REFIL IN 06/2005, IT WAS NOTED THAT EXPECTED RESERVOIR VOLUME WAS .3 CCS; ACTUAL RESERVOIR VOLUME WAS 17 CCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK MEDTRONIC, INC., NEUROLOGICAL DIV 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention IMPLANTED:| CATHETER MODEL CATHETER LOT#UNK,| EXPLANTED: