BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88

    MDR report key: 2902985 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-11901
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A BURNING SENSATION IN THE MIDDLE OF HER BACK. IT WAS REPORTED THE SENSATION WAS NOT RELATED TO THE IPG POCKET. THE PT HAD EFFECTIVE STIMULATION. F/U IDENTIFIED SURGICAL INTERVENTION WOULD BE UNDERTAKEN AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 3727448

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)