BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961317 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-05513
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ST JUDE MED - 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 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.

    Description of Event or Problem · 1

    THE PATIENT HAS TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT HAS BEEN RECEIVING UNCOMFORTABLE STIMULATION IN AN UNINTENDED AREA SINCE FALLING. REPROGRAMMING TO PROVIDE RESOLUTION WAS UNSUCCESSFUL. AS A RESULT, X-RAYS WILL BE TAKEN FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421167 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3186 4246488

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other SCS IPG, MODEL: 3716| IMPLANT:| IMPLANT:| SCS ANCHORS, MODEL: 1192(X2)