BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD

    MDR report key: 1800766 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01939
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 SEE (MFR# 1627487-2010-01913). ON 03/05/2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. PT WAS IN A MOTOR VEHICLE ACCIDENT. SINCE THE ACCIDENT THE PT HAS BEEN REPROGRAMMED 4 TIMES. THE PT USED THE STIMULATION DURING THE DAY AND TURNED IT OFF AT NIGHT. THE PT SAID THEY WOULD SOMETIMES GET A BURNING OR SHOCKING SENSATION HALFWAY BETWEEN THE IPG AND LEAD SITE. THE DOCTOR REPLACED ENTIRE SYSTEM AND PT IS DOING VERY WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3146 33661

    Patients

    Seq Age Sex Outcome Treatment
    1 Other