BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2791998 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-01858
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-01857. IT WAS REPORTED DURING THE PROCEDURE TO REMOVE THE TRIAL LEADS, ONE OF THE LEADS FRACTURED AS THE PHYSICIAN ATTEMPTED TO REMOVE IT. A PORTION OF THE LEAD REMAINED IN THE PATIENT'S BODY. LATER THE SAME DAY, A SECOND PHYSICIAN SUCCESSFULLY REMOVED THE PORTION OF THE LEAD FROM THE PATIENT'S BODY. THE PATIENT EXPERIENCED NO COMPLICATIONS FROM THE REMOVAL AND PLANS TO MOVE FORWARD WITH THE PERMANENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3646037

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention