BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192107 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-13944
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 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

    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 TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED DURING A TRIAL PROCEDURE SEVERAL ELECTRODES ON ONE OF THE LEADS HAD INVALID IMPEDANCES. THE PHYSICIAN REPOSITIONED THE LEAD AND THE ISSUE WAS RESOLVED. IT WAS NOTED THE PROCEDURE WAS EXTENDED BY 30 MINUTES. THE PATIENT HAD EFFECTIVE STIMULATION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280775 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3986353

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other