BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2000945 · Received February 18, 2011

    Report

    Report Number
    1627487-2011-02228
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ST. JUDE MEDICAL- NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WAS TO RECEIVE HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA FOR THE PROCEDURE. THE PATIENT AWOKE FROM ANESTHESIA IMMEDIATELY AFTER THE FIRST LEAD WAS IMPLANTED. AS THE PATIENT BEGAN MOVING AROUND UPON WAKING, THE CLINICIANS HELD HIM DOWN UNTIL THE EPIDURAL NEEDLE AND LEAD WERE REMOVED. THE LEAD WAS EXPLANTED AND DISCARDED BY THE FACILITY. THE SURGERY WAS ABORTED. IT IS CURRENTLY NOT KNOWN IF THE PATIENT WILL BE IMPLANTED AT A LATER DATE. FOLLOW UP FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3186 3240575

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention