BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1101829 · Received August 7, 2008

    Report

    Report Number
    9614453-2008-04751
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS INVOLVED IN A MOTORCYCLE ACCIDENT. AT THE TIME OF THE ACCIDENT, THE PT FELT A "STRONG IMPACT" AT THE IPG IMPLANT SITE. THE PT FELT AN UNCOMFORTABLE STIMULATION THAT CONTINUED TO GET WORSE OVER TIME. THE IPG WAS CHECKED; BUT NO ABNORMALITY WAS FOUND WITH ELECTRICAL CURRENT AND IMPEDANCE. DUE TO THE PT REQUEST, THE IPG WAS REPLACED AND THE PT RECEIVED STIMULATION AGAIN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention LEAD MODEL 3887 LOT# V074426| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3887 LOT# V074426| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU162621V| EXPLANTED,| EXTENSION MODEL 7482 LOT# NHU161021V