BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1895283 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-09050
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFLAMMATORY MASS. AN MRI WAS TAKEN AND CONFIRMED A GRANULOMA. SHE ALSO STATED THAT FOR THE PAST FOR 4 MONTHS HER LEGS HAD "GOTTEN PROGRESSIVELY WORSE, LIKE THERE'S A DISCONNECT." SHE "CAN'T SEEM TO HAVE CONTROL" OVER HER LEGS WHEN SHE INITIALLY STOOD UP FROM A SITTING POSITION. THE PATIENT ALSO REPORTED THAT HER CATHETER BROKE AND WAS REVISED. IT IS BELIEVED THAT THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 3007566237-2009-09247. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other ACCESSORY: MODEL 8590-1, LOT# N174343| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N175091025| EXPLANTED:| EXPLANTED:| IMPLANTED: