BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2881927 · Received December 20, 2012

    Report

    Report Number
    1644487-2012-03423
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 8, 2006
    Report Date
    November 30, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED THAT WITH THE VNS DOSAGE CHANGES, THE PATIENT'S SEIZURES HAVE IMPROVED AND HE WILL CONTINUE BEING TREATED WITH VNS.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED THAT INDICATED THAT PATIENT EXPERIENCED AN INCREASE IN SEIZURE FREQUENCY AS NOTED ON (B)(6) 2006. SEIZURES WERE OCCURRING EVERY FEW MONTHS BUT THE PHYSICIAN NOTED THAT THEY HAD RECENTLY BEEN OCCURRING EVERY COUPLE OF WEEKS TO EVERY WEEK. THE VNS PARAMETERS WERE IN THE PROCESS OF BEING INCREASED, AND THE PATIENT'S ANTI-EPILEPTIC MEDICATION WAS INCREASED. THE NEXT VISIT ON (B)(6) 2006, THE PATIENT REPORTED THAT HE WAS TOLERATING THE VNS WITHOUT DIFFICULTY. ON (B)(6) 2007, THE PATIENT REPORTED THAT HIS SYMPTOMS WERE ABOUT THE SAME SINCE THE PREVIOUS VISITS. ACCORDING TO THE PATIENT'S CAREGIVER, THE SEIZURES WERE NOT QUITE AS SEVERE AS BEFORE. THE OUTPUT CURRENT WAS INCREASE TO 1.5MA. CLINIC NOTES DATED (B)(6) 2007 REVEALED THAT THE PATIENT HAD A "PRODROME OR SOME WARNING THAT A SEIZURE WAS GOING TO OCCUR. THIS IS NOT TYPICAL FOR HIM." THE PATIENT HAD THREE SEIZURES WITHIN A FEW DAYS OF HIS LAST VISIT. THE OUTPUT CURRENT WAS INCREASED TO 1.5MA. THE PATIENT'S VNS OUTPUT CURRENT WAS TITRATED UP THROUGHOUT 2007. LATER IN CLINIC NOTES DATED (B)(6) 2007 THAT THE PATIENT PRESENTED AND REPORTED THAT HE HAD BEEN SEIZURE FREE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014585

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention