BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2001422 · Received January 10, 2011

    Report

    Report Number
    3004209178-2011-00203
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION WHEN LYING DOWN AND GOING TO BED. THIS ISSUE BEGAN ABOUT 2 WEEKS AGO AND THERE WAS NO KNOWN FALLS OR TRAUMA ASSOCIATED WITH THIS EVENT. SHE ALSO HAD WEAKNESS AND PAIN IN HER RIGHT LEG EVEN WHEN THE STIMULATION WAS TURNED DOWN. THE PT ADJUSTED THE STIMULATION BOTH UP AND DOWN, BUT WAS NOT GETTING RELIEF FROM HER PAIN. SHE TURNED HER STIMULATION OFF ON SATURDAY AND STILL FELT THE SHOCKING SENSATION. ADD'L INFO 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 71 YR LEAD: MODEL 3999, LOT# V002755| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU104629V| PROGRAMMER: MODEL 7435, LOT# NFT057612P| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU115087V