BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 3517614 · Received December 12, 2013

    Report

    Report Number
    1644487-2013-03750
    Event Type
    Death
    Date Received
    December 12, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PARTICULAR REPORT HOUSES A DEATH DUE TO A SPECIFIC TYPE, NO INFORMATION IS AVAILABLE ON THE CAUSE OF DEATH OF THE CORRESPONDING PATIENT, BUT THIS REPORT WILL TRACE THIS SPECIFIC DEATH REPORT TO A KNOWN PATIENT. (B)(4)

    Description of Event or Problem · 1

    PATIENT INFORMATION HAS BEEN RECEIVED; HOWEVER, NO INFORMATION HAS BEEN RECEIVED IN WHICH MANNER THE PATIENTS PASSED AWAY. THE DEATHS WERE REPORTED TO NOT BE RELATED TO VNS.

    Description of Event or Problem · 1

    THE PATIENT¿S DEATH CERTIFICATE CANNOT BE OBTAINED DUE TO STATE LAWS, BUT THE PATIENT¿S TREATING PHYSICIAN WAS IDENTIFIED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NO FURTHER DETAILS HAVE BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE ABSTRACT FOR THE ARTICLE ¿MAJOR HEALTH ISSUES IN A COHORT OF EPILEPSY PATIENTS TREATED WITH VAGUS NERVE STIMULATION THERAPY¿ WAS RECEIVED AND REVIEWED BY THE MANUFACTURER. THE FOLLOWING IS THE ABSTRACT FOR THE ARTICLE: RATIONALE: VAGUS NERVE STIMULATION (VNS) IS AN ADJUNCTIVE TREATMENT FOR REFRACTORY EPILEPSY. PATIENTS WITH VNS TYPICALLY HAVE SEVERE EPILEPSY AND MAY HAVE GREATER MEDICAL COMORBIDITY THAN SIMILARLY AGED COHORTS. THE VNS DEVICE CAN COMPLICATE THE MANAGEMENT OF COMORBID CONDITIONS AS SOME PROCEDURES ARE CONTRAINDICATED BY THE DEVICE, OR WILL REQUIRE ADDITIONAL SAFEGUARDS. TO DATE, THERE HAVE BEEN FEW STUDIES DESCRIBING EPILEPSY SEQUELAE AND COMORBIDITY IN THE VNS TREATED PATIENT POPULATION. THIS STUDY AIMED TO IDENTIFY MAJOR HEALTH ISSUES IN PATIENTS WITH REFRACTORY EPILEPSY TREATED WITH LONG-TERM VNS. METHODS: A RETROSPECTIVE ANALYSIS OF MAJOR HEALTH ISSUES, INCLUDING SIGNIFICANT MEDICAL ISSUES AND SIDE EFFECTS, WAS PERFORMED IN A COHORT OF 52 EPILEPSY PATIENTS TREATED WITH VNS. SIGNIFICANT MEDICAL ISSUES WERE DEFINED AS MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, CANCER, CHRONIC PULMONARY CONDITIONS, CHRONIC GASTROINTESTINAL CONDITIONS, ACUTE PULMONARY EVENTS, ACUTE GASTROINTESTINAL EVENTS, SEIZURE-RELATED INJURY, SUICIDE ATTEMPT, AND DEATH. RESULTS: THE MEAN AGE AT VNS INITIATION AND TIME OF STUDY WAS 39.5 AND 48.3 YEARS, RESPECTIVELY. MEAN DURATION OF THERAPY WAS 8.9 YEARS. SIDE EFFECTS LIMITING THERAPY WERE OBSERVED IN 15.4% OF PATIENTS. AT LEAST ONE SIGNIFICANT MEDICAL ISSUE WAS SEEN IN 38.5% OF PATIENTS. DEATH (19.2%), SEIZURE-RELATED INJURY (15.4%), CHRONIC PULMONARY CONDITIONS (11.5%), AND ACUTE PULMONARY EVENTS (9.6%) WERE MOST COMMONLY OBSERVED. DEATH OCCURRED AFTER A MEAN 8.3 YEARS OF VNS THERAPY AT 54.9 YEARS OF AGE, ATTRIBUTABLE TO CANCER IN THREE (5.7%) CASES AND LIKELY TO SUDDEN UNEXPECTED DEATH IN EPILEPSY (SUDEP) IN TWO (3.8%) CASES. LACK OF FOLLOW-UP LIMITED VNS MANAGEMENT IN 25.0% OF PATIENTS, REPRESENTING AN ADDITIONAL CHALLENGE IN THIS POPULATION. THE VNS DEVICE MITIGATED MEDICAL MANAGEMENT IN FIVE CASES, INCLUDING THREE CANCERS, ONE PULMONARY, AND ONE EMERGENCY SURGERY. CONCLUSIONS: WHILE SOME ILLNESS MAY BE ANTICIPATED DUE TO AGING AND EPILEPSY REFRACTORY TO TREATMENT, COMORBIDITY AND MORTALITY IN THIS COHORT WERE GREATER THAN EXPECTED. CONSEQUENTLY, KNOWLEDGE OF HOW VNS IMPACTS MEDICAL MANAGEMENT IN BOTH ACUTE CARE AND OUTPATIENT SETTINGS IS ESSENTIAL. FURTHERMORE, MEDICAL COMORBIDITY MAY HAVE BEEN UNDER BASED ON THE NUMBER OF PATIENTS IN THE STUDY AND THE PERCENTAGES PROVIDED, THERE WERE 10 DEATHS REPORTED (TWO DUE TO SUDEP, THREE DUE TO CANCER, AND FIVE FROM UNKNOWN CAUSE), ONE PATIENT WHO EXPERIENCED AN ADVERSE EVENT REQUIRING EMERGENCY SURGERY, AND ONE PULMONARY EVENT IN WHICH SURGERY COULD NOT OCCUR. THESE EVENTS WERE REPORTED ON THE FOLLOWING MANUFACTURER REPORTS: 1644487-2013-03741¿REPORTS THE 1ST PATIENT'S DEATH DUE TO SUDEP; 1644487-2013-03742 ¿ REPORTS THE 2ND PATIENT'S DEATH DUE TO SUDEP; 1644487-2013-03743 ¿ REPORTS THE 3RD PATIENT'S DEATH DUE TO CANCER; 1644487-2013-03744 ¿ REPORTS THE 4TH PATIENT'S DEATH DUE TO CANCER; 1644487-2013-03745 ¿ REPORTS THE 5TH PATIENT'S DEATH DUE TO CANCER; 1644487-2013-03746 ¿ REPORTS THE 6TH PATIENT'S DEATH (DUE TO UNKNOWN REASON); 1644487-2013-03747¿ REPORTS THE 7TH PATIENT'S DEATH (DUE TO UNKNOWN REASON); 1644487-2013-03748¿ REPORTS THE 8TH PATIENT'S DEATH (DUE TO UNKNOWN REASON); 1644487-2013-03749¿ REPORTS THE 9TH PATIENT'S DEATH (DUE TO UNKNOWN REASON); 1644487-2013-03750¿ REPORTS THE 10TH PATIENT'S DEATH PATIENT (DUE TO UNKNOWN REASON); 1644487-2013-03751 - REPORTS THE PATIENT WITH ADVERSE EVENT REQUIRING EMERGENCY SURGERY; 1644487-2013-03752¿ REPORTS THE PATIENT WITH SERIOUS INJURY DYSPNEA [ONE PULMONARY EVENT IN WHICH SURGERY COULD NOT OCCUR].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650165 PULSE GEN MODEL 100 GENERATOR LYJ CYBERONICS, INC. 100 12088C

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death