BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4051482 · Received September 2, 2014

    Report

    Report Number
    1644487-2014-02141
    Event Type
    Death
    Date Received
    September 2, 2014
    Date of Event
    March 8, 2012
    Report Date
    August 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2012 AND THE PATIENT'S CAUSE OF DEATH WAS MAJOR CARDIOVASCULAR DISEASE WITH OTHER FORMS OF CHRONIC ISCHEMIC HEART DISEASE, PERICARDIAL EFFUSION (NONINFLAMMATORY), PLEURAL EFFUSION, NOT ELSEWHERE CLASSIFIED, PLEURAL EFFUSION, NOT ELSEWHERE CLASSIFIED, AND RESPIRATORY FAILURE, UNSPECIFIED. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF NOT SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Description of Event or Problem · 1

    THE DEATH CERTIFICATE WAS RECEIVED ON 01/06/2015 AND REPORTED DATE OF DEATH AS (B)(6) 2012. THE PATIENT PASSED AWAY AS AN INPATIENT IN A HOSPITAL. CAUSE OF DEATH WAS RESPIRATORY FAILURE (3 DAYS) DUE TO (OR AS A CONSEQUENCE OF) PERICARDIAL EFFUSION (2 WEEKS) DUE TO (OR AS A CONSEQUENCE OF) PLEURAL EFFUSIONS (2 WEEKS) DUE TO (OR AS A CONSEQUENCE OF) MYOCARDIAL INFARCTION (ONE MONTH). NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. FURTHER FOLLOW-UP REVEALED THAT THE DATE AND CAUSE OF DEATH ARE UNKNOWN AS THE CARE RESIDENCE NO LONGER HAD THE PATIENT'S RECORDS AT THE FACILITY. THE RELATIONSHIP OF THE VNS TO THE CAUSE OF DEATH IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535073 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201324

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death