BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4167523 · Received October 13, 2014

    Report

    Report Number
    1644487-2014-02673
    Event Type
    Death
    Date Received
    October 13, 2014
    Date of Event
    January 8, 2013
    Report Date
    September 17, 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
    OTHER

    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

    AN EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS FROM ANOTHER MEDICAL DEVICE MANUFACTURER. THE DEVICES HAD BEEN INADVERTENTLY RETURNED TO THE WRONG MANUFACTURER. IT WAS NOTED THAT THE VNS PATIENT HAD PASSED AWAY. IT WAS NOTED THAT IN THE LAST SEVERAL WEEKS THE PATIENT HAD BEEN FEELING WEAK AND HIS BREATHING HAD STOPPED. THE PATIENT WAS UNRESPONSIVE ON ARRIVAL. NO CAUSE OF DEATH OR RELATIONSHIP OF THE DEATH TO VNS WAS INDICATED. IT WAS NOTED THAT AN AUTOPSY WAS PERFORMED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. ANALYSIS OF THE DEVICES ARE UNDERWAY, BUT HAVE NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR AND LEAD WAS COMPLETED. AN END-OF-SERVICE (EOS) CONDITION WAS FOUND WITH PULSE GENERATOR. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED LEAD PORTION. NOTE THAT SINCE A LARGE PORTION OF THE LEAD ASSEMBLY WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    THIS DEATH INFORMATION HAS BEEN REVIEWED BY THE MEDICAL DEVICE MANUFACTURER AND WITH THE AVAILABLE INFORMATION HAS BEEN DETERMINED TO BE POSSIBLE SUDEP. IT IS NOT KNOWN WHAT STATE OF HEALTH THE PATIENT WAS IN, OR THE MANNER OF DEATH, OR THE CAUSE OF DEATH. THE PHYSICIAN'S OFFICE WAS UNABLE TO PROVIDE ANY INFORMATION AS THEY HAD NO RECORDS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647709 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death