BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN 101

    MDR report key: 4506952 · Received February 11, 2015

    Report

    Report Number
    1644487-2015-03776
    Event Type
    Death
    Date Received
    February 11, 2015
    Date of Event
    February 22, 2013
    Report Date
    January 20, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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) 2013. THE PATIENT';S DEVICE HAD REACHED END OF SERVICE PRIOR TO THE PATIENT¿S DEATH. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100511 PULSE GEN 101 GENERATOR LYJ CYBERONICS INC 101 2375

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death