BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON-C 16-CHANNEL IPG

    MDR report key: 1854228 · Received September 3, 2010

    Report

    Report Number
    1627487-2010-02507
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS 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

    ON (B)(6) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT SAID THAT ON (B)(6) 2010, THEIR PROGRAMMER DISPLAYED THE MESSAGE "STIM OFF". THE PT DOES NOT FEEL ANY STIMULATION. SURGERY IS PENDING TO REPLACE THE PT'S IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON-C 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3688 175760

    Patients

    Seq Age Sex Outcome Treatment
    1 Other