BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3221535 · Received July 9, 2013

    Report

    Report Number
    1627487-2013-12911
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    December 31, 2011
    Report Date
    June 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2013-12910. IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO PAINFUL SHOCKING WITH STIMULATION ON OR OFF. THE PATIENT ALSO EXPERIENCED A BURNING SENSATION DOWN HER SPINE AND LEGS. THE PATIENT REPORTED REPROGRAMMING DID NOT SOLVE THE ISSUES. THE PATIENT DOES NOT KNOW THE EXACT DATE OF THE EXPLANT, BUT IT WAS IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313578 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 50529

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other