BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1880166 · Received October 15, 2010

    Report

    Report Number
    1627487-2010-02883
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD WAS VISUALLY INSPECTED; SLIGHT DISCOLORATION WAS OBSERVED IN THE LEAD SEGMENT. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE LEAD WAS SUBJECTED TO FUNCTIONAL TESTING AND FAILED CONTINUITY AND STRESS TESTING ON CHANNEL 4. ALL OTHER CHANNELS PASSED AND MEASURED LESS THAN 4 OHMS. CONCLUSION: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR TWITCHING AND PANIC ATTACKS. THE LEAD DID, HOWEVER FAIL CONTINUITY AND STRESS TESTING ON CHANNEL 4. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. PLEASE SEE MFR REPORT# 1627487-2010-02852 FOR DEVICE 1. ON (B)(6) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, THE SALES REPRESENTATIVE WAS INFORMED THAT THE PT'S IPG WAS EXPLANTED ON (B)(6) 2010. THE DOCTOR REMOVED THE SYSTEM BECAUSE THE PT BELIEVED IT MADE HIM TWITCH AND HAVE PANIC ATTACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 173008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other