BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110617 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-08065
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED TWO TRIAL LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT FELT NO STIMULATION DURING THE PROCEDURE AND THE DIAGNOSTIC RESULTS SHOWED INVALID IMPEDANCE ON THE FIRST LEAD PLACED. THE PHYSICIAN TRIED ANOTHER LEAD BUT HAD THE SAME RESULTS. THUS, THE PROCEDURE WAS ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208702 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3970256

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention