BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2020288 · Received March 11, 2011

    Report

    Report Number
    1644487-2011-00430
    Event Type
    Death
    Date Received
    March 11, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    R.E. ELLIOTT ET AL. VAGUS NERVE STIMULATION IN 436 CONSECUTIVE PATIENTS WITH TREATMENT-RESISTANT EPILEPSY: LONG TERM OUTCOMES AND PREDICTORS OF RESPONSE. EPILEPSY & BEHAVIOR 2011;20:57 -63.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE FOLLOWING 436 CONSECUTIVE PTS IMPLANTED WITH VNS THAT TWELVE PTS DIED DUE TO UNRELATED CAUSES. IT IS UNK IF "UNRELATED" MEANS UNRELATED TO EPILEPSY OR UNRELATED TO VNS. THIS MDR WILL HOUSE THE SEVENTH PT THAT DIED DUE TO UNRELATED CAUSES. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO INCLUDING PT AND PRODUCT INFO TO DETERMINE IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED TO THE MFR HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death