BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 5539040 · Received March 31, 2016

    Report

    Report Number
    1627487-2016-01634
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    March 7, 2016
    Report Date
    March 7, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT CONTINUED TO EXPERIENCE UNINTENDED RIB/ABDOMINAL STIMULATION AFTER THE LEAD WAS REPOSITIONED (REFERENCE MFR. REPORT: 1627487-2016-000938). SURGICAL INTERVENTION IS PLANNED AS THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193983 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4103511

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other MODEL 1192 (X2), SCS ANCHOR