BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1953519 · Received January 5, 2011

    Report

    Report Number
    1644487-2011-02975
    Event Type
    Injury
    Date Received
    January 5, 2011
    Report Date
    December 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ABSTRACT FOR ARTICLE ENTITLED "NO INFECTION IN 100 CONSECUTIVE CASES OF VAGUS NERVE STIMULATION FOR TREATMENT OF REFRACTORY EPILEPSY" BY HORACIO SENTIES-MADRID, ET. AL. THAT THE PHYSICIAN HAS NOT SEEN AN INFECTION IN 100 CONSECUTIVE COMPLETED VNS IMPLANTS. HOWEVER, IT NOTES THAT "SINCE VAGAL NERVE STIMULATION WAS ADDED INTO THE SURGICAL ARMAMENTARIUM FOR TREATMENT OF REFRACTORY EPILEPSY, INFECTIONS HAVE BEEN REPORTED IN 1-6% OF CASES." IT IS UNK WHERE THIS INFO REGARDING INFECTION RATE IS FROM AS THE ABSTRACT DOES NOT HAVE REFERENCES AND THE FULL ARTICLE HAS NOT YET BEEN OBTAINED FOR REVIEW. PER AUTHOR, THEY BELIEVE THAT IF PROPER PROCEDURES ARE FOLLOWED WITH USE OF PROPHYLACTIC ANTIBIOTICS ON GOOD SURGICAL CANDIDATES, THE "INFECTION RATE FOR VNS SHOULD BE NIL." ATTEMPTS TO OBTAIN THE FULL ARTICLE FOR REVIEW ARE UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening