BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16 CHANNEL IMPLANTABLE PULSE GENERATOR

    MDR report key: 1220471 · Received November 4, 2008

    Report

    Report Number
    1627487-2008-00038
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. IPG WAS RETURNED WITH HEADER MATERIAL CUT, CUT IN ANTENNA SILICON, AND INSTRUMENT MARKS ON HEADER MATERIAL. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. VISUAL EXAMINATION FOUND SLIGHT DISCOLORATION ON SEPTUM BUT NO OTHER ANOMALIES. DEVICE PASSED FUNCTIONAL AND COMMUNICATION TESTING. ANS, INC. HAS LIMITED INFO 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, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 5 OF 5 (REFER TO MFR'S REPORT NUMBER 1627487-2008-00034 FOR DEVICE 1, 1627487-2008-00035 FOR DEVICE 2, 1627487-2008-00036 FOR DEVICE 3, AND 1627487-2008-00037 FOR DEVICE 4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16 CHANNEL IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR (IPG) GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 119790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other