BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3161434 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-06400
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 WAS IMPLANTED WITH TWO SYSTEMS, ONE FOR SCS AND ONE FOR PNS (OFF-LABEL) STIMULATION THERAPY. THE PNS SYSTEM WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED ONE OF THE PATIENT'S LEAD FOR THE PNS SYSTEM MOVED AND ERODED OUT THROUGH HER SKIN. THE ENTIRE PNS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249332 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3816521

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (X2)| IMPLANT DATE: