BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3872661 · Received June 13, 2014

    Report

    Report Number
    1644487-2014-01501
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    January 16, 2012
    Report Date
    May 16, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    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 [DATE OF DEATH] AND THE PATIENT'S CAUSE OF DEATH WAS: I. INFANTILE CEREBRAL PALSY, UNSPECIFIED; II. PNEUMONIA, UNSPECIFIED; III. OTHER AND UNSPECIFIED ABNORMALITIES OF BREATHING; IV. OTHER SPECIFIED SYMPTOMS AND SIGNS INVOLVING THE CIRCULATORY AND RESPIRATORY SYSTEMS. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT PASSED AWAY IN THE HOSPITAL. THE CAUSE OF DEATH WAS LISTED AS RESPIRATORY INSUFFICIENCY, PNEUMONIA, AND CEREBRAL PALSY. IT WAS REPORTED THAT THE DEVICE WAS BURIED WITH THE PATIENT; THEREFORE WILL NOT BE RETURNED FOR ANALYSIS. THE RELATIONSHIP OF VNS THERAPY TO THE PATIENT'S 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
    349553 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 009728

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death