BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S4

    MDR report key: 4202013 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-05718
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 1, 2013
    Report Date
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT #: 1627487-2014-05717. IT WAS REPORTED THE PT LOST STIMULATION OVER TIME AFTER EXPERIENCING SEVERAL FALLS. TROUBLESHOOTING BY AN SJM REPRESENTATIVE WAS UNSUCCESSFUL. X-RAYS WERE TAKEN AND NO ANOMALIES WERE FOUND. THE NEXT COURSE OF ACTION IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663379 LAMITRODE S4 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3246 33343

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3346| IMPLANTED:| SCS LEAD: MODEL 3186| SCS IPG: MODEL 3716| IMPLANTED:| SCS EXTENSION: MODEL 3386