BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141254 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-01585
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 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

    THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION AND IS EXPERIENCING A PULLING SENSATION IN HER RIGHT LEG. A SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS SHOWED ALL CONTACTS WERE INVALID. REPROGRAMMING WAS ONLY ABLE TO CAPTURE LEFT SIDE COVERAGE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231050 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3787865

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788