BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY EZ PATIENT PROGRAMMER

    MDR report key: 1052532 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02745
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DROPPED THEIR PROGRAMMER IN THE WATER. THE PATIENT COULD NOT GET THE PROGRAMMER TO SHUT THE NEUROSTIMULATOR OFF. THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION AT THE PARESTHESIA AREA. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE EMERGENCY ROOM DID NOT HAVE AN 8840 PROGRAMMER TO SHUT OFF THE PATIENT'S NEUROSTIMULATOR. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY EZ PATIENT PROGRAMMER LGW MEDTRONIC NEUROMODULATION 7435 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANTABLE LEADS AND EXTENSIONS MODEL UNK| LOT # UNKNOWN| IMPLANTABLE NEUROSTIMULATOR MODEL 7427