BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3252155 · Received July 25, 2013

    Report

    Report Number
    1627487-2013-06670
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    April 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P01000032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 3. REFERENCE MFR REPORT: 1627487-2013-06669. REFERENCE MFR REPORT: 1627487-2013-00671. IT WAS REPORTED THE PT'S IPG HAS MOVED AND IS CAUSING DISCOMFORT. THE PT STATED THAT APPROXIMATELY TWO MONTHS AGO SHE NOTICED HER IPG HAD MOVED FROM HER BUTTOCK AND OVER HER SPINE AND IT IS VERY SUPERFICIAL AND UNCOMFORTABLE. IT WAS ALSO REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. THE PT STATED HER HEADACHES AND FATIGUE HAVE INCREASED IN THE LAST YEAR AND A HALF. THE PT IS PENDING A FOLLOW-UP WITH AN SJM REPRESENTATIVE TO EVALUATE HER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348300 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3181 84762

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other