BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1213071 · Received October 23, 2008

    Report

    Report Number
    2182207-2008-06842
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MULTIPLE MOTOR STALLS AND RECOVERIES WERE REPORTED. ACCORDING TO THE TELEMETRY STRIPS, THE STALLS LASTED BETWEEN 45 MINUTES TO 5-1/2 HOURS. THE PATIENT EXPERIENCED INCREASED PAIN DURING THE TIME OF THE STALLS. THE PATIENT DENIED BEING AROUND A MAGNETIC FIELD, BUT THE HCP BELIEVES THAT THE PATIENT WAS. THE PUMP WAS USED TO DELIVER MORPHINE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC| IMPLANTED:| EXPLANTED: