BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 1833023 · Received September 2, 2010

    Report

    Report Number
    1627487-2010-02436
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    April 5, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2 (SEE MFR# 1627487-2010-02544). ON (B)(6)2009, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. LEADS MIGRATED LATERALLY AND THE PATIENT WAS GETTING RIB AND ABDOMEN STIMULATION ONLY. THE PATIENT WAS IMPLANTED WITH A PADDLE LEAD AND IS DOING WELL NOW. THE LEADS WERE EXPLANTED AND DISCARDED. THE IPG WAS ELECTIVELY REPLACED AS WELL AND NEITHER OF THE DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD SPINAL CORD, IMPLANTABLE, (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 2743951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other