BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3241217 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02429
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1142-2008 SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID UNKNOWN, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4). CORRECTION/REMOVAL NUMBERS: Z-1143-2008; Z-1144-2008; Z-1145-2008; Z-1146-2008; Z-1147-2008; Z-1148-2008; Z-1149-2008;Z-1150-2008;Z-1151-2008; Z-1152-2008; Z-1153-2008; Z-1154-2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFLAMMATORY MASS WAS SUSPECTED. A CT SCAN WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340206 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other