BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1674008 · Received April 30, 2010

    Report

    Report Number
    1627487-2010-00409
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    September 1, 2009
    Report Date
    October 12, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN A RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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 RECEIVED HER SCS SYSTEM ON (B) (6) 2009. IT WAS REPORTED TO ANS THAT THE PATIENT PASSED AWAY AROUND (B) (6) 2009. THE PATIENT'S SCS DEVICES WERE NOT RETURNED TO ANS FOR EVALUATION. ANS CONTACTED THE IMPLANTING PHYSICIAN FOR ADDITIONAL INFORMATION. THE PHYSICIAN STATED THAT THE PATIENT WAS IN POOR HEALTH AND ALSO OBESE. HE SAID THAT ABOUT 2 WEEKS POST-OPERATIVE, THE PATIENT DEVELOPED A WOUND INFECTION AT THE IMPLANT SITE. THE PHYSICIAN WAS TREATING THE INFECTION WHICH HE STATED WAS HEALING SUCCESSFULLY. THE PHYSICIAN STATED THAT THE PATIENT DIED IN THE HOSPITAL, BUT HE WAS NOT NOTIFIED UNTIL 2-3 DAYS LATER. HE SAID, THE PATIENT WAS STILL IMPLANTED WITH THE SCS SYSTEM BUT HE WAS NOT SURE IF IT WAS BEING USED AT THE TIME OF THE PATIENT'S DEATH. NO AUTOPSY WAS PERFORMED TO CONFIRM THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 174191

    Patients

    Seq Age Sex Outcome Treatment
    1 Death