BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1873576 · Received September 22, 2010

    Report

    Report Number
    1627487-2010-02553
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: VISUAL INSPECTION AND FUNCTIONAL TESTING WERE COMPLETED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: SCRATCHES WERE OBSERVED IN THE CAN AND CUTS WERE SEEN IN THE HEADER. DISCOLORATION WAS OBSERVED IN BOTH SEPTUM. THE IPG SUCCESSFULLY COMMUNICATED WITH A LAB PT PROGRAMMER. THE IPG WAS ALSO TESTED ON THE AUTO-TESTER AND PASSED. CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED FOR "NO COMMUNICATION." AS RECEIVED, THE IPG COMMUNICATED WITH A LAB PT PROGRAMMER AND THE CHARGER. 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. PLEASE SEE MFR REPORT # 1627487-2010-02552 FOR DEVICE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2744488

    Patients

    Seq Age Sex Outcome Treatment
    1 Other