BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 5262908 · Received December 3, 2015

    Report

    Report Number
    1644487-2015-06628
    Event Type
    Death
    Date Received
    December 3, 2015
    Date of Event
    November 1, 2015
    Report Date
    November 9, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY WAS INADVERTENTLY REPORTED AS THE DEATH WAS BELIEVED TO NOT BE RELATED TO VNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY IN EARLY (B)(6) 2015. THE PATIENT'S DEVICE HAD BEEN DISABLED FOR YEARS PRIOR TO THE DEATH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN OBTAINED TO DATE.

    Description of Event or Problem · 1

    DUE TO THE INFORMATION THAT THE PATIENT'S VNS DEVICE HAD BEEN DISABLED FOR YEARS PRIOR TO THE PATIENT'S DEATH, THIS DEATH IS BELIEVED TO BE UNRELATED TO VNS SURGERY OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794249 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 011066

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death