BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3201794 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-05907
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 9, 2011
    Report Date
    June 3, 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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-05908. THE PT HAS TWO LEADS FROM THE SAME LOT. THE PT HAS BEEN UNABLE TO USE HER SCS SYSTEM ACCORDINGLY DUE TO BOTH LEADS MIGRATING. ALSO, ONE OF THE LEAD IS DISCONNECTED FROM THE IPG. AS A RESULT, THE PT PLANS TO UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290593 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3224266

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other