BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2133432 · Received June 15, 2011

    Report

    Report Number
    1644487-2011-01328
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN'S OFFICE THAT THE PT HAD BEEN HAVING "INCREASED EVENTS." THE SITE FELT THAT THE VNS BATTERY WAS DEPLETING, CAUSING THE ISSUES. THE PT'S CURRENT SETTINGS WERE 0.75 MA, PULSE WIDTH 250, FREQ 30HZ, ON TIME 30 SEC, OFF TIME 5.0, MAGNET CURRENT 1.00 MA, PULSE WIDTH 500. THE PT'S LAST KNOWN DIAGNOSTIC TESTS SHOWED PROPER DEVICE FUNCTION. FURTHER INFO REVEALED THAT THE PT WAS BEING REFERRED FOR A PROPHYLACTIC REPLACEMENT DUE TO THE SEIZURES. THE PHYSICIAN HAD INCREASED THE PT'S MEDICATIONS SLIGHTLY WITH NO BENEFIT, AND THE PT'S MOTHER REFUSES TO ALLOW TITRATION OF THE VNS. CLINIC NOTES FROM THE PHYSICIAN'S OFFICE STATED THAT ON (B)(6) 2011 THE MOTHER HAD NOTED A "SIGNIFICANT CHANGE IN SEIZURE FREQUENCY" IN THE PAST 2 WEEKS. BESIDES HAVING THE USUAL "NIGHT EVENTS", THE PT WAS NOT HAVING "DAY EVENTS" AS WELL. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 8125

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention