BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S4

    MDR report key: 2921658 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-02061
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    November 1, 2007
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    REFERENCE REPORT # 1627487-2013-02062 AND 1627487-2013-02063. THE PATIENT RECEIVED FOUR LEADS FROM THREE SEPARATE LOTS AS PART OF HER TWO SCS SYSTEMS. IT WAS REPORTED, THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION IN THE PELVIC REGION. THE PATIENT UNDERWENT A TRIAL PROCEDURE ON (B)(6) 2012 TO ATTEMPT TO ADDRESS THE ISSUE. AS THE LOCATION OF THE LEADS IS UNKNOWN, THE AFFECTED DEVICES ARE UNDETERMINED. THEREFORE, ALL OF THE PATIENT'S LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15592 LAMITRODE S4 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3246 46638

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788