BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3926331 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-25446
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 #: 1627487-2014-25445. THE PT REPORTED HE WANTS TO UNDERGO SURGICAL INTERVENTION TO HAVE HIS SCS SYSTEM EXPLANTED DUE TO NEVER RECEIVING EFFECTIVE STIMULATION AND THE SYSTEM WAS TOO COMPLICATED TO USE. ADDITIONALLY, THE PT STATED HIS BACK SURGERY ON (B)(6) 2013 HELPED HIM MORE WITH HIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355966 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3595378

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788