BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1243710 · Received November 25, 2008

    Report

    Report Number
    6000032-2008-07737
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    May 5, 2004
    Report Date
    October 27, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATION SUDDENLY STOPPED. THE DEVICE WAS REPLACED. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| IMPLANTED:| EXTENSION: MODEL 7495-25| IMPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435| EXTENSION: MODEL 7495-25| EXPLANTED:| IMPLANTED: