BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1634697 · Received March 17, 2010

    Report

    Report Number
    1627487-2010-00114
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ANS HAS LIMITED INFORMATION 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

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING SENSATION AT THE IPG POCKET WHEN THE STIM IS TURNED ON. PT STATED THAT THE SENSATION IS STRONGER WHEN THE IPG IS TURNED ON WITH THE PROGRAMMER AND WHEN CONNECTING TO THE CHARGER. THE X-RAY REVEALED THAT THE CONNECTIONS APPEARED TO BE INTACT AND THERE WAS NO DAMAGE TO THE COIL ON THE IPG. THE IPG WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 174562

    Patients

    Seq Age Sex Outcome Treatment
    1 Other