BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44

    MDR report key: 2934287 · Received January 7, 2013

    Report

    Report Number
    1627487-2013-13021
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    May 24, 2011
    Report Date
    December 13, 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 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 FROM HIS SCS SYSTEM. REPROGRAMMING COULD NOT BE ATTEMPTED DUE TO THE PATIENT NOT HAVING HIS PROGRAMMER AT THE APPOINTMENT. THE PATIENT STATED HE WANTED THE SCS SYSTEM EXPLANTED. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO EXPLANT THE PATIENT'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8654 LAMITRODE 44 SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3244 2804901

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS LEAD: MODEL 3163