BEUDAMED
    FDA Adverse Event Other Summary report: N

    EONC IMPLANTABLE PULSE GENERATOR

    MDR report key: 1034970 · Received April 25, 2008

    Report

    Report Number
    1627487-2008-00007
    Event Type
    Other
    Date Received
    April 25, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ANS INC. 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 INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN EONC IPG IN 2008. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AND THE IPG WAS EXPLANTED THE FOLLOWING MONTH. THE PHYSICIAN HAS NOT MADE ANY COMMENTS ON THE CAUSE OF THE PT'S REPORTED INFECTION. THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO ANS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR GZB ADVANCED NEUROMODULATION SYSTEMS 3688 113980

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other