BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2090740 · Received April 26, 2011

    Report

    Report Number
    1644487-2011-00896
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN'S CLINIC NOTES WERE RECEIVED BY THE MANUFACTURER'S CASE MANAGEMENT. UPON REVIEW OF THE CLINIC NOTES DATE (B)(6), 2011, IT WAS NOTICED THAT THE VNS PATIENT WAS EXPERIENCING A GENERALIZED TONIC-CLONIC SEIZURE ONE OR TWO WEEKS PRIOR AND OVER THE LAST FEW WEEKS SHE HAS NOTICED SOME CHANGES IN HER MOOD AND SOME PRESSURE IN HER EARS AS WELL. THE VNS BATTERY APPEARED TO BE WORKING WELL AND SYSTEM DIAGNOSTICS REVEALED NO PROBLEMS. THE PHYSICIAN REPORTS THAT IN THE PAST, THE PATIENT WAS UNABLE TO TOLERATE STIMULATION INTENSITY OF 2.5MA OR HIGHER BECAUSE THEY HAVE RESULTED IN EAR SYMPTOMS. THE PATIENT HAS BEEN DOING QUITE WELL AND HAS BEEN SEIZURE FREE FOR AT LEAST SIX MONTHS BEFORE THE GENERALIZED TONIC-CLONIC SEIZURE RECENTLY. THE PHYSICIAN SAID IF SHE CONTINUES TO HAVE SEIZURES, HE WILL EITHER ADJUST HER VNS SETTINGS OR ADD A SECOND MEDICATION. THE PATIENT WENT FOR BATTERY REPLACEMENT SURGERY ON (B)(6), 2011 FOR UNKNOWN REASONS. IT IS LIKELY THAT IT WAS DUE TO CLINICAL EOS, HOWEVER THAT HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2011, AND IT HAS NOT YET BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010324

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR