BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1823418 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-02426
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    January 12, 2010
    Report Date
    May 10, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND THERE WAS A NON-CONFORMANCE FOUND THAT WAS IDENTIFIED TO A SPECIFIC SERIAL NUMBER. THE AFFECTED DEVICE WAS SCRAPPED. THE IPG IN THIS COMPLAINT WAS NOT AFFECTED BY THE NON-CONFORMANCE. 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT HAS LOST A LOT OF WEIGHT AND THE IPG HAS DROPPED IN POCKET, SUCH THAT THE PATIENT IS NOW SITTING ON IT AND IN A LOT OF PAIN. THE PATIENT HAD BATTERY REPLACEMENT SURGERY ON (B)(6) 2010. HER SYSTEM WAS FUNCTIONAL BUT HAD DROPPED DOWN VERY LOW IN HER BUTTOCKS. THE IMPEDANCES ON THE LEAD WERE CHECKED INTER-OPERATIVELY AND WERE FOUND TO BE IN NORMAL RANGE. THE IPG WAS STILL FUNCTIONAL BUT WAS CHANGED OUT DUE TO AGE DURING THE REVISION. THE PATIENT IS DOING WELL POST-OPERATIVELY AND IS HAPPY WITH HER STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 46341A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other