BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88

    MDR report key: 2940593 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-13121
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    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 INFO 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 PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION COVERAGE. THE PATIENT'S LEADS WERE REPOSITIONED TO RECAPTURE THE PATIENT'S RIGHT SIDE PAIN COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38832 LAMITRODE 88 SCS LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3288 2935476

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788