BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 804066 · Received December 28, 2006

    Report

    Report Number
    6000030-2006-02377
    Event Type
    Malfunction
    Date Received
    December 28, 2006
    Date of Event
    November 20, 2006
    Report Date
    November 27, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    p860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXPLANTED PUMP CONFIRMED PHYSICIAN REPORT OF AN INSUFFICIENT BOND OF THE CATHETER ACCESS PORT TO THE PUMP.

    Description of Event or Problem · 1

    HCP REPORTED THE INFUSION PUMP WAS EXPLANTED AND RETURNED TO MANUFACTURER FOR ANALYSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 82 MONTHS DUE TO BATTERY DEPLETION. IN ADDITION, THE PHYSICIAN NOTED THE CATHETER SIDE PORT CAME OFF DURING PUMP REMOVAL. THERE WERE NO PATIENT SYMPTOMS, OR INJURY REPORTED. THE EXPLANTED PUMP WAS REPLACED WITH A NEW SYNCHROMED II PUMP AND FILLED WITH 1000MCG/ML BACLOFEN FOR TREATMENT OF INTRACTABLE SPASTICITY DUE TO CEREBRAL PALSY DIAGNOSIS. SEE MANUFACTURER REPORT # 6000030-2006-02379.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization CATHETER MODEL#8709, LOT #L71604, IMPL| EXPLANTED