BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1051663 · Received May 19, 2008

    Report

    Report Number
    6000030-2008-02672
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0022-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED THE CATHETER ACCESS PORT WAS LIFTED BUT WAS STILL FUNCTIONAL/ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PUMP WAS REPLACED DUE TO BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention CATHETER MODEL 8703W LOT# L39973| PROGRAMMER MODEL UNKNOWN LOT# UNKNOWN| IMPLANTED| EXPLANTED