BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1070462 · Received July 7, 2008

    Report

    Report Number
    6000030-2008-03796
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 7, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. RESULTS CODE OTHER = CATHETER. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PUMP WAS REPLACED DUE TO BATTERY DEPLETION. THE CATHETER WAS REMOVED DUE TO A BREAK, TEAR OR HOLE. THERE WAS NO PATIENT INJURY. NO SYMPTOMS OR OUTCOME WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 64 YR Required Intervention CATHETER MODEL 8709 LOT # J11802R02 IMPLANTED:| EXPLANTED| PROGRAMMER MODEL UNK LOT# UNKNOWN