BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850694 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-26427
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    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 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 HAS A SCS SYSTEM WHICH INCLUDES TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. X-RAY IMAGERY CONFIRMED BOTH LEADS HAD MIGRATED. THE PATIENT UNDERWENT A SURGICAL LEAD PROCEDURE WHERE TWO LEADS WERE EXPLANTED AND REPLACED WITH ONE NEW LEAD. THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303385 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4294618

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS ANCHOR: MODEL 1192| IMPLANT:| SCS IPG: MODEL 3788| IMPLANT: