BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3890711 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-01383
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 13, 2014
    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 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 RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE COVERAGE TO HIS FEET. THE PT HAS PERIPHERAL NEUROPATHY. ADDITIONAL REPROGRAMMING WILL BE ATTEMPTED. FOLLOW-UP IDENTIFIED REPROGRAMMING CAPTURE STIMULATION TO THE LEGS AND FEET; HOWEVER, STIMULATION WAS ALSO FELT IN THE ABDOMEN. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324893 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4357087

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1192(2)| SCS IPG: MODEL 3788