BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2780725 · Received October 5, 2012

    Report

    Report Number
    1627487-2012-12235
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 INFORMATION 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 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12236. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION COVERAGE IN HIS FEET. THE SJM REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING. IT WAS REPORTED ONE OF THE LEADS COULD NOT BE USED DUE TO UNWANTED STIMULATION. THE PHYSICIAN REQUESTED AN X-RAY. AN ATTEMPT TO DETERMINE THE NEXT COURSE OF ACTION WAS UNSUCCESSFUL. NOTE THIS PT IS IMPLANTED WITH TWO LEAD OF THE SAME MODEL, FROM TWO DIFFERENT LOT NUMBERS. BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3491148

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)