BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1181773 · Received September 30, 2008

    Report

    Report Number
    6000032-2008-06245
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S STIMULATION TARGET WAS HER WAIST DOWN TO HER FEET. AFTER HELPING A FRIEND MOVE, THE PATIENT EXPERIENCED STIMULATION IN HER LOWER BACK. SHE HAD STIMULATION IN HER SHOULDERS WHETHER THE IMPLANTABLE NEUROSTIMULATOR WAS ON OR OFF. THE PATIENT FELT A COLD SENSATION DOWN HER BACK LIKE 'SOMETHING IS RUNNING DOWN IT'. THE PATIENT CONTINUED TO FEEL STIMULATION IN HER TARGET AREAS. HER STATUS WAS REPORTED AS 'GOOD'. THE PATIENT HAD NOT SEEN HER MANAGING PHYSICIAN IN YEARS AND WAS PROVIDED A LIST OF HCP'S. 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 57 YR EXTENSION: MODEL 7495-51| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3988| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51