BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2855231 · Received December 3, 2012

    Report

    Report Number
    1644487-2012-03181
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIANS OFFICE. IT WAS NOTED THAT THEY HAD AN INCREASE IN SEIZURE ACTIVITY RECORDED. THE PATIENT'S MOTHER REPORTED THAT THEIR MAGNET WAS NOT AS EFFECTIVE AS USED TO BE PREVIOUSLY. THE CAUSE OF THE PATIENT'S LACK OF EFFICACY WAS REPORTED TO BE UNCERTAIN. THE PATIENT HAS TUBEROUS SCLEROSIS AND INTRACTABLE EPILEPSY. THE ORIGINAL VNS WAS IMPLANTED AND SUBSEQUENTLY REPLACED IN (B)(6) 2009 BECAUSE OF HIGH LEAD IMPEDANCE DC/DC 7 AND DETERIORATION IN EPILEPSY. ADDRESSED IN MEDWATCH REPORT NUMBER: 1644487-2011-00877. THE SURGEON HAD WRITTEN TO US TO SAY THE LEAD WAS REPLACED AT THIS TIME AND WAS HELD TOGETHER TIGHTLY WITH SCAR TISSUE. ONE WONDERED AT THE TIME IF THE VAGAL NERVE COULD HAVE BEEN DAMAGED. THE SURGEON SAID THIS IS A POSSIBILITY. THEIR DEVICE HAS BEEN RAMPED UP FURTHER THAN PREVIOUS DEVICE AND CYCLING INCREASED. MAGNET SETTING INCREASED FOR 3 MONTH TRIAL PERIOD TO SEE IF EFFECTIVE ON HIGH SETTING. THE PATIENT'S SEIZURE RATE WAS BELOW BASELINE AND STILL IMPROVED FROM BEFORE ORIGINAL IMPLANT IN 2002.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT'S DEVICE WAS NOT AS EFFECTIVE AS BEFORE. THEY HAD REVISION SURGERY PREVIOUSLY WITH FIBROSIS ON THEIR IN THEIR ELECTRODE LOCATION. SINCE THAT TIME THE PATIENT'S MOTHER DOESN'T FEEL IT IS AS EFFECTIVE NOW. IT IS UNKNOWN IF THAT MEANS AN INCREASE IN SEIZURES OR LACK OF EFFICACY. GOOD FAITH ATTEMPTS WILL BE MADE FOR FURTHER DETAILS ABOUT THE REPORTED EVENT. DATE OF EVENT UNKNOWN THEREFORE USED (B)(6) 2012 REPORT DATE. WILL UPDATE AS FURTHER INFORMATION IS ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201033

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR