BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2081331 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02969
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION. THE PATIENT HAS INCREASED "OUTPUT IN THE GROIN AREA", WHICH AFFECTED HER BALANCE. THE DEVICE HAD BEEN TURNED OFF FOR A YEAR, BUT THE PATIENT STILL FELT STIMULATION. A FRIEND SUGGESTED THAT THE PATIENT PLACE A COPPER WIRE OVER THE DEVICE SITE AND RUN IT DOWN TO HER FEET, WHICH CAUSED STIMULATION ONLY IN HER FOOT, RATHER THAN THE GROIN. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3587A, LOT # N0025473| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT # NFT040411P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT # N0025473| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU071894V| IMPLANTED: