BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2480831 · Received March 6, 2012

    Report

    Report Number
    1644487-2012-00628
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    January 1, 1994
    Report Date
    February 7, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VAGUS NERVE STIMULATION FOR REFRACTORY IDIOPATHIC GENERALIZED EPILEPSY. NG, MICHAEL AND DEVINSKY, ORRIN. SEIZURE. 2004. 13: 176-178.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN THE ARTICLE TITLED "VAGUS NERVE STIMULATION FOR REFRACTORY IDIOPATHIC GENERALIZED EPILEPSY" THAT THERE WERE 18 PATIENTS WHO WERE IDENTIFIED AS RESPONDERS BUT HAD AN INCREASE IN SEIZURES FREQUENCY. SIXTEEN PATIENTS HAD PARTIAL EPILEPSY, ONE HAD SYMPTOMATIC GENERALIZED EPILEPSY AND ONE HAD PRIMARY GENERALIZED EPILEPSY. A RESPONDER WAS DEFINED FOR THE STUDY AS A PATIENT WITH A >50% REDUCTION IN SEIZURES AND A CONCURRENT REDUCTION OF MEDICATION REGIME. NO FURTHER INFORMATION WAS PROVIDED. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THIS MDR IS FOR ONE OF THE PATIENT'S WITH PARTIAL EPILEPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS 10X NI

    Patients

    Seq Age Sex Outcome Treatment
    1