BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1935936 · Received December 3, 2010

    Report

    Report Number
    3007566237-2010-10172
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    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

    THE PERSONAL THERAPY MANAGER (PTM) DISPLAYED CODE 8476; MOTOR STALL. THE PT WAS GOING TO THE EMERGENCY ROOM AND THE LOCAL PHYSICIAN WAS BEING CONTACTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANTED:| CATHETER: MODEL 8598, LOT# N002319932| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8596, LOT# N002344431