BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2363787 · Received December 8, 2011

    Report

    Report Number
    1644487-2011-03020
    Event Type
    Death
    Date Received
    December 8, 2011
    Date of Event
    May 28, 2011
    Report Date
    November 9, 2011
    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

    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 PATIENT PASSED AWAY DUE TO COMPLICATIONS FROM PNEUMONIA. THE RELATIONSHIP BETWEEN THE PATIENT'S PNEUMONIA AND VNS IS CURRENTLY UNKNOWN. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PATIENT'S FUNERAL HOME FOR PRODUCT RETURN REVEALED THAT THE PATIENT'S DEVICES WERE NOT EXPLANTED AT THE TIME OF THE PATIENT'S DEATH, AS THE PATIENT WAS BURIED AND THE FUNERAL HOME ONLY EXPLANTS MEDICAL DEVICES WHEN THE PATIENT IS CREMATED AND/OR AT THE FAMILY'S REQUEST. THEY DID NOT HAVE ANY EXPLANTED DEVICES FOR THIS PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S PNEUMONIA WAS NOT RELATED TO VNS, AND THE PATIENT'S DEATH WAS NOT RELATED TO VNS.

    Description of Event or Problem · 1

    DURING A REVIEW OF AVAILABLE PROGRAMMING HISTORY, HIGH IMPEDANCE WAS IDENTIFIED ON THE DATE OF INITIAL IMPLANT. THIS WAS PREVIOUSLY REPORTED UNDER MEDWATCH # 1644487-2005-00892.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 013389

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death