BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3231099 · Received July 17, 2013

    Report

    Report Number
    3007566237-2013-02370
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS IMPLANTED IN (B)(6) AND HE RECENTLY MOVED BACK TO (B)(6). THE PATIENT WAS UNABLE TO FIND A DOCTOR WHO WOULD SERVICE THE PUMP. THE PUMP WAS EMPTY. THE PATIENT WAS IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331058 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1