BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6198332 · Received December 22, 2016

    Report

    Report Number
    1644487-2016-02938
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    March 26, 2015
    Report Date
    February 15, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP COMMUNICATIONS WITH THE CORONER FOR THE COUNTY IN WHICH THE PATIENT PASSED AWAY SHOWED THAT THE PATIENT WAS NOT A CASE OF THEIRS. COMMUNICATION WITH THE HOSPITAL THE CORONER REFERENCED SHOWED THEY DO NOT HAVE INFORMATION RELATING TO THE PATIENT¿S DEATH OR DISCHARGE FROM THEIR FACILITY. FOLLOW UP WITH THE SERVICING FUNERAL HOME SHOWED THAT THEY DO NOT HAVE A PLACE WHERE EXPLANTED DEVICES ARE STORED. ACCORDING TO THEIR PROCESS, IF THE PATIENT WAS CREMATED, THEIR DEVICE WOULD HAVE BEEN DISPOSED, AND IF THE PATIENT WAS BURIED, IT WOULD HAVE BEEN LEFT IMPLANTED. NO OTHER PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS LISTED AS DECEASED AT THE TREATING PHYSICIAN¿S OFFICE. AN ONLINE OBITUARY WAS FOUND WHICH INDICATING THE DATE THAT THE PATIENT PASSED AWAY. THE GENERATOR AND LEAD DEVICE HISTORY RECORDS WERE REVIEWED ON 12/22/2016 AND FOUND THAT ALL SPECIFICATIONS WERE MET PRIOR TO DISTRIBUTION. ATTEMPTS FOR ADDITIONAL PERTINENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847945 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202128

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death