BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3111519 · Received May 14, 2013

    Report

    Report Number
    1644487-2013-01364
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    February 10, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THIS VNS PATIENT USUALLY HAD ONE TO THREE SEIZURES EVERY OTHER DAY, BUT IN THE LAST TWO MONTHS, THE PATIENT NOTICED AN INCREASE IN SEIZURES ACTIVITY AND EVEN MORE DURING THE NIGHT TIME. THE PATIENT HAD A HISTORY OF MULTIPLE EPISODES OF STATUS EPILEPTICUS, THE LAST OF WHICH WAS IN (B)(6) 2010. IN (B)(6) 2012, THE PATIENT'S SEIZURE BASELINE WAS FIVE PER WEEK. FOLLOW-UP SHOWED THAT THE PATIENT'S PRE-VNS HISTORY INCLUDED EPISODE OF STATUS EPILEPTICUS AND THIS WAS JUST PART OF THE PATIENT'S SEIZURES PATTERN. THE RELATION OF THE INCREASE IN SEIZURES TO THE PRE-VNS BASELINE WAS UNKNOWN, AND NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PATIENT WAS REFERRED FOR GENERATOR REVISION. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(4) 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT GENERATOR REVISION ON (B)(6) 2013. THE EXPLANTING FACILITY DOES NOT RETURN PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212925 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201130

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other