BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1800005 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01802
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD: 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

    ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PROGRAMMER STOPPED POWERING ON AND THE BATTERY PACK WAS REPLACED. AFTER BATTERY REPLACEMENT, THE PROGRAMMER FUNCTIONED, BUT ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT NO LONGER EXPERIENCED STIMULATION SENSATION EVEN AT MAXIMUM SETTINGS. IPG WILL BE EXPLANTED AND REPLACED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 38755A

    Patients

    Seq Age Sex Outcome Treatment
    1