BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904100 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-01725
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    June 9, 2009
    Report Date
    June 9, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REVIEWED 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. (B)(4). 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

    THE PT RECEIVED HIS SCS SYS CONSISTING OF ONE SURGICAL LEAD AND AN IPG ON (B)(6) 2007. THE IPG WAS REPORTEDLY CAUSING THE PT DISCOMFORT IN THE IMPLANT POCKET SITE. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG. THE PHYSICIAN IMPLANTED THE NEW IPG IN A DIFFERENT LOCATION. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR EVAL. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 83312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention