BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1890261 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08338
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    THE PATIENT BENT OVER IN A "VERY TIGHT SPACE" AND SINCE THEN "HAS FELT STIM 3 INCHES FROM THE SPINE ON THE RIGHT SIDE." THE PATIENT FELT THAT THE "LEAD WIRE MAY HAVE COME OFF OF SPINE" AND WAS "FEELING UNCOMFORTABLE STIM AROUND LEAD LOCATION WITH INS ON OR OFF." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 57 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU084490V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0511591V| EXTENSION: MODEL 7489, LOT# NHU087803V| PROGRAMMER: MODEL 7435, LOT# NFT049055P| EXPLANTED: