BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3113019 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02629
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 PT UNDERWENT A TRIAL SCS IMPLANT PROCEDURE. IT WAS REPORTED THE LEAD WAS PULLED OUT OF THE PACKAGING AND THE LEAD/STYLET WAS BENT. THE PHYSICIAN ATTEMPTED TO IMPLANT THE LEAD BUT WAS UNABLE TO STEER IT DUE TO THE ISSUE. THE LEAD WAS DISCARDED AND A SECOND LEAD WAS OPENED AND IMPLANTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204802 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3932300

    Patients

    Seq Age Sex Outcome Treatment
    1