BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1981366 · Received February 1, 2011

    Report

    Report Number
    6000032-2011-00756
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FELL. AFTERWARD THE PATIENT FELT A WARMING AROUND THE IMPLANT SITE. HE ONLY FELT STIMULATION ON ONE SIDE OF HIS BACK AND A BURNING SENSATION. A COMPUTED AXIAL TOMOGRAPHY SCAN WAS DONE BUT THE CAUSE OF THE BURNING SENSATION COULD NOT BE DETERMINED. THE PATIENT STATUS WAS REPORTED AS 'FAIR'. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| LEAD: MODEL 3998, LOT# LA5497| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT021646P| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK015089V| IMPLANTED:| EXPLANTED:| EXTENTION: MODEL 7495LZ, LOT# NHK015027V| EXPLANTED: