BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2031348 · Received March 16, 2011

    Report

    Report Number
    3007566237-2011-02019
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PT'S CATHETER WAS FRACTURED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L' INFO 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 55 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# J11656R11| IMPLANTED: