BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1904075 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02368
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. IPG PASSED ALL TESTING INCLUDING THE SALINE TEST FOR OVERSTIMULATION. 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 REC'D HER SCS SYSTEM INCLUDING AN IPG AND PADDLE LEAD ON (B)(6) 2007. IT WAS REPORTED IN (B)(6) 2010 THAT THE PT BEGAN EXPERIENCING A HEATING SENSATION AT THE IPG SITE ABOUT 6 MONTHS PRIOR WHEN FIRST TURNING STIMULATION ON. LEAD IMPEDANCE MEASUREMENTS FOUND HIGH VALUES FOR THE LEAD. IT WAS REPORTED THAT ULTIMATELY THE ALLEGED POCKET HEATING WOULD OCCUR WHETHER STIMULATION WAS ON OR OFF AND THE RECHARGING TIME HAD BECOME LONGER. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2010. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE IS NO FURTHER INFORMATION 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 68515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention