BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110656 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-12646
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFO 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

    DEVICE 2 OF 2. REF MFR REPORT #1627487-2013-12645. IT WAS REPORTED THE PT IS EXPERIENCING UNINTENDED STIMULATION. X-RAYS REVEALED NO ANOMALIES. THE SJM REP REPROGRAMMED AND PT IS RECEIVING EFFECTIVE STIMULATION COVERAGE FOR ESTABLISHED PAIN PATTERN, BUT IS STILL EXPERIENCING UNINTENDED STIMULATION. NOTE: THE PT HAS TWO LEADS WITH DIFFERENT LOT NUMBERS, BOTH ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208990 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3186 3108757

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: