BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 5293316 · Received December 14, 2015

    Report

    Report Number
    1644487-2015-06724
    Event Type
    Death
    Date Received
    December 14, 2015
    Date of Event
    October 20, 2006
    Report Date
    November 17, 2015
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2006 AND THE PATIENT'S CAUSE OF DEATH WAS OTHER ILL-DEFINED AND UNSPECIFIED CAUSES OF MORTALITY. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED BY A PANEL OF EXPERT MEDICAL PROFESSIONALS AND IT WAS DETERMINED ON (B)(6) 2015 THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF DEFINITE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. THE PULSE GENERATOR WAS RECEIVED HAVING TOOLS MARKS, WHICH MAY HAVE BEEN ATTRIBUTED TO THE EXPLANT PROCESS. OTHER THAN THE TOOLING MARKS, NO SURFACE ABNORMALITIES (SUCH AS SHARP EDGES, HEADER DELAMINATION, OPEN POCKETS, OR VOIDS) WERE NOTED ON THIS DEVICE. THE PULSE GENERATOR WOULD INTERROGATE AND PROGRAM AT A DISTANCE OF ONE INCH FROM THE PROGRAMMING WAND. THE OUTPUT OF THE PULSE GENERATOR WAS LOADED AND MONITORED AT BODY TEMPERATURE FOR 29.0 HOURS; THE OUTPUT REMAINED WITHIN SPECIFICATION FOR THE ENTIRE TIME. THE PULSE GENERATOR IS OPERATING WITHIN DESIGNED LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822681 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 12704

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death