BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110773 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-15617
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PT HAS TWO LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. THE PT REPORTED SHE IS NOT RECEIVING ADEQUATE STIMULATION IN HER PAIN AREAS. PT INDICATED SHE ONLY FEELS STIMULATION IN HER LEGS AND THE STIMULATION MAKES HER LOSE HER BALANCE WHILE WALKING. THE SJM REP WAS TO CONTACT THE PT AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204660 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3382890

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788