BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3820933 · Received May 12, 2014

    Report

    Report Number
    1627487-2014-05334
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    ON (B)(6) 2014, THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. THE PROCEDURE WAS ABANDONED DUE TO THE DOCTOR BEING UNABLE TO PLACE TWO LEADS (FROM THE SAME LOT) BECAUSE OF THE PT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284848 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4444499

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other