BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901992 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09382
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS OF THE CATHETER WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED DECREASED EFFICACY OF THERAPY. THE CATHETER WAS REPLACED DUE TO A BREAK/TEAR/HOLE. THE PUMP DELIVERED LIORESAL 500 MCG/ML AT 60 MCG/DAY. THE PT RECOVERED WITHOUT SEQUELAE.

    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 55 YR Other IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N245548| CATHETER: MODEL 8711, LOT# N246643003| EXPLANTED:| EXPLANTED: