BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1222823 · Received August 25, 2008

    Report

    Report Number
    2182207-2008-05206
    Event Type
    Malfunction
    Date Received
    August 25, 2008
    Date of Event
    June 27, 2007
    Report Date
    July 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED A STIMULUS FROM THE IMPLANT DURING A COMPUTERIZED TOMOGRAPHY SCAN. NO PT SYMPTOMS OR DEVICE TROUBLESHOOTING WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC NEUROMODULATION 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL UNK| IMPLANTED:| EXPLANTED: