BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1973645 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-00415
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 1, 2006
    Report Date
    January 6, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS RUN OVER BY AN (B)(6) IN 2006 AND HER PT PROGRAMMER WAS EITHER LOST OR RUN OVER DURING THE ACCIDENT AND SHE HASN'T USED IT SINCE. SHE ALSO STATED SHE HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING SOME SORT OF TRAUMA IN 2006. PT WAS PARALYZED FROM THE WAIST DOWN AS A RESULT OF THE ACCIDENT. SHE IS CURRENTLY LOOKING FOR A NEW PHYSICIAN TO MANAGE HER STIMULATION THERAPY BUT HAS NOT FOUND ONE YET. SHE IS WONDERING IF THE 7427 STIMULATOR WILL STILL WORK IF SHE RECEIVES A NEW PROGRAMMER AND THE ANSWER TO HER QUESTION IS UNK AT THIS TIME. SHE WAS ENCOURAGED TO FIND A NEW PHYSICIAN TO ADDRESS HER DEVICE ISSUES. ADDITIONAL INFO WAS REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 33 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT # J0424818V| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT # NFT042010P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU056067V| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU056069V| IMPLANTED:| EXPLANTED: