BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3874055 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-05387
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    February 1, 2013
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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

    IT WAS REPORTED THE PATIENT HAS NEVER RECEIVED ADEQUATE COVERAGE. IN TURN, THE PATIENT DECIDED TO UNDERGO A TRIAL PROCEDURE ON (B)(6) 2014. UNFORTUNATELY, THE TRIAL DID NOT ADDRESS THE ISSUE. AS A RESULT, THE PATIENT HAS CHOSEN TO CONTINUE MEDICAL MANAGEMENT AND UTILIZE HER SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314495 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3861960

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other MODEL: 1192 (X2), SCS ANCHORS,| MODEL: 3788, SCS IPG,