BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1580983 · Received January 15, 2010

    Report

    Report Number
    1627487-2010-00014
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 11, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 1 OF 6: (REFER TO MFR'S REPORT NUMBERS: 1627487-2010-0015 FOR DEVICE 2, 1627487-2010-0016 FOR DEVICE 3, 1627487-2010-0017 FOR DEVICE 4, 1627487-2010-0018 FOR DEVICE 5, AND 1627487-20100-0019 FOR DEVICE 6). IT WAS REPORTED, PT ARRIVED AT ER IN 2010, SEPTIC AND WITH A POST-OP WOUND INFECTION, PT DIED THE FOLLOWING MORNING. CAUSE OF DEATH IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 2876099

    Patients

    Seq Age Sex Outcome Treatment
    1 Death