BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3940480 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-03432
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2014-03432. IT WAS REPORTED DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY STEERING THE 1ST LEAD. THE PHYSICIAN USED ANOTHER LEAD; HOWEVER, DUE TO THE PATIENT'S ANATOMY WAS UNABLE TO PLACE IT IN THE INTENDED LOCATION. THE PROCEDURE WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357596 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS 3186 4354425

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other