BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3092852 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01238
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 1, 2012
    Report Date
    April 5, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DORIS D. WANG, ABBY E. DEANS, A. JAMES BARKOVICH, TARIK TIHAN, NICHOLAS BARBARO, PAUL A. GARCIA, AND EDWARD F. CHANG. "TRANSMANTLE SIGN IN FOCAL CORTICAL DYSPLASIA: A UNIQUE RADIOLOGICAL ENTITY WITH EXCELLENT PROGNOSIS FOR SEIZURE CONTROL". J NEUROSURG. 2013 FEB;118(2):337-44. DOI: 10.3171/2012.10.JNS12119. EPUB 2012 DEC 7.

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF AN ARTICLE (WANG DD, DEANS AE, BARKOVICH AJ, TIHAN T, BARBARO NM, GARCIA PA, CHANG EF. TRANSMANTLE SIGN IN FOCAL CORTICAL DYSPLASIA: A UNIQUE RADIOLOGICAL ENTITY WITH EXCELLENT PROGNOSIS FOR SEIZURE CONTROL. J NEUROSURG. 2013 FEB;118(2):337-44. DOI: 10.3171/2012.10.JNS12119. EPUB 2012 DEC 7.) IT WAS NOTED THAT ONE PATIENT THAT WAS IMPLANTED WITH VNS HAS A WORSENING OF SEIZURES. THE PATIENT WAS (B)(6) OF AGE AT THE TIME OF IMPLANT AND A MALE. THE PATIENT HAD GTC WITH AN ONSET OF SEIZURES AT (B)(6) OF AGE. THE PATIENT HAD DAILY SEIZURES AND THERE WERE NO ASSOCIATED SYMPTOMS. THE LOCATION OF THE MRI ANOMALY IS LEFT FRONTAL MULTIGYRAL. ON THE MRI IT APPEARED TO BE AN APPEARED CORTICAL THICKENING, T2/FLAIR ANOMALY, MEDIAL TEMPORAL SCLEROSIS, BOTTOM-OF-SULCUS DYSPLASIA AND TRANSMALTLE DYSPLASIA. THIS PATIENT HAD MULTIPLE SUBPIAL TRANSSCETIONS AND VNS AND CONTINUED TO HAVE RESIDUAL SEIZURES. NO TISSUE WAS SENT TO PATHOLOGY AND THE PATIENT. THE PATIENT HAD PERSISTENT SEIZURES FOLLOWING THE TRANSECTIONS AND A WORSENING OF SEIZURES. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195070 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1