BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4186604 · Received October 20, 2014

    Report

    Report Number
    1644487-2014-02765
    Event Type
    Death
    Date Received
    October 20, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    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
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2014. THE PATIENT WAS EXPERIENCING CHEST PAIN THE NIGHT BEFORE HIS DEATH BUT DID NOT GO TO THE HOSPITAL. THE PATIENT WAS FOUND DEAD ON HIS BED THE MORNINIG OF (B)(6) 2014. THE DEATH CERTIFICATE LISTED THAT CAUSED OF DEATH AS CARDIAC ARREST DUE TO ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS BURIED WITH HIS DEVICE SO NO ANALYSIS CAN BE PERFORMED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRE-EXISTING CARDIAC ISSUES AND WAS 5'8" TALL AND OVER 300 POUNDS. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS NOT RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665824 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202803

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death