BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1804163 · Received August 11, 2010

    Report

    Report Number
    1627487-2010-02401
    Event Type
    Death
    Date Received
    August 11, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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

    EVALUATION - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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 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)2006, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6)2010, IT WAS REPORTED THAT THE PATIENT DIED. ON 8/5/2010, SJM CONTACTED THE PATIENT'S IMPLANTING PHYSICIAN FOR ADDITIONAL INFORMATION. THE PHYSICIAN WAS UNAWARE OF THE PATIENT'S CAUSE OF DEATH. THE DOCTOR MENTIONED THAT THE PATIENT HAD BEEN SEEING A CARDIOLOGIST BUT REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION.

    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 48272

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O