BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3201809 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-08257
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - 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 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

    IT WAS REPORTED THE PT UNDERWENT A TRIAL WITH THE LEADS IN THE SUPRA-ORBITAL PLACEMENT (OFF-LABEL USE) AND THE RIGHT SIDE CAME OUT OVER NIGHT. THE PT HAD COMPLETE LOSS OF STIMULATION ON THE RIGHT SIDE. THE PHYSICIAN MET WITH THE PT ON (B)(6) 2013; IT WAS DECIDED TO LEAVE THE RIGHT LEAD OUT AND CONTINUE THE TRIAL WITH THE EXISTING LEFT LEAD. THE DOCTOR DESCRIBED ANTIBIOTICS AND THERE WAS NO SIGN OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291336 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4037093

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SCS LEAD: MODEL 3086| IMPLANT: