BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON MINI IPG

    MDR report key: 1559673 · Received December 11, 2009

    Report

    Report Number
    1627487-2009-00141
    Event Type
    Death
    Date Received
    December 11, 2009
    Date of Event
    October 24, 2009
    Report Date
    November 16, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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 OR 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

    THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM IN 2009. THE PATIENT WAS LAST SEEN AT THE DOCTOR'S OFFICE THE FOLLOWING MONTH, AND HAD BEEN ON ORAL ANTIBIOTIC THERAPY FOR THREE WEEKS. A CULTURE OF THE IPG POCKET WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL THREE DAYS LATER, FOR ASYSTEMATIC INFLAMMATORY RESPONSE SYNDROME. THE SCS SYSTEM WAS REMOVED THE SAME DAY AND DISCARDED. THE PATIENT WAS PLACED ON A PIC LINE FOR IV ANTIBIOTIC THERAPY THE FOLLOWING DAY, AND RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. THE PATIENT PASSED AWAY THE NEXT DAY. IT WAS REPORTED THAT THE PHYSICIAN STATED THE DEATH WAS LIKELY DUE TO A PULMONARY EMBOLISM OR MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG IMPLANTABLE PULSE GENERATOR (IPG) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2834058

    Patients

    Seq Age Sex Outcome Treatment
    1 Death