BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2457069 · Received February 16, 2012

    Report

    Report Number
    1644487-2012-00415
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    April 1, 2011
    Report Date
    January 18, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: LATE ONSET ICTAL ASYSTOLE IN REFRACTORY EPILEPSY; JULES C. BEAL MD, YOSHIMI SOGAWA MD, SCOTT R. CERESNAK MD, JOSEPH MAHGEREFTEH MD, SOLOMON L. MOSHÉ MD. PEDIATRIC NEUROLOGY 45 (2011) 253-255

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE PUBLISHED ARTICLE ENTITLED "LATE ONSET ICTAL ASYSTOLE IN REFRACTORY EPILEPSY; JULES C. BEAL MD, YOSHIMI SOGAWA MD, SCOTT R. CERESNAK MD, JOSEPH MAHGEREFTEH MD, SOLOMON L. MOSHÉ MD. PEDIATRIC NEUROLOGY 45 (2011) 253-255" NOTED A PATIENT HAD AN INFECTION AT THE VNS GENERATOR SITE REQUIRING EXPLANTATION OF THE DEVICE, AND THE PATIENT WAS NOT REIMPLANTED. THE EXACT EVENT DATE OF THE INFECTION IS UNKNOWN. THE ARRHYTHMIA EVENTS THE PATIENT EXPERIENCED ARE BEING REPORTED SEPARATELY VIA MDR REPORT #1644487-2012-00412. ATTEMPTS FOR FURTHER INFORMATION FROM THE ARTICLE AUTHOR ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention