BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1871028 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02653
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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

    ON (B)(6) 2006, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED ON (B)(6) 2010 THAT OVER THE LAST YEAR THE PT HAD PAIN OVER THE IPG POCKET AND IN THE LAST MONTH A SHOCKING SENSATION STARTED IN THE POCKET AREA. THE PT HAS NOT FALLEN OR EXPERIENCED ANY TRAUMATIC EVENTS, AND X-RAYS DON'T REVEAL ANY PROBLEMS. THE IMPEDANCE READINGS ARE ALL AROUND 349. THE PHYSICIAN HAS SCHEDULED A REVISION TO A NEW IPG IN ABOUT A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 56159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other