BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2770769 · Received October 3, 2012

    Report

    Report Number
    1644487-2012-02503
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4), 2013 ADDITIONAL PROGRAMMING HISTORY WAS RECEIVED FOR THE PATIENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED WHICH INDICATES THE PATIENT HAD REPLACEMENT SURGERY ON (B)(6) 2013 DUE TO BATTERY DEPLETION. NO OTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE VNS PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES THAT DAY. THE PATIENT'S SETTINGS WERE NOTED TO BE OUTPUT=2.25MA/FREQUENCY=30HZ/PULSE WIDTH=250USEC/ON TIME=21SEC/OFF TIME=3MIN/MAGNET OUTPUT=2.75MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. A DIAGNOSTICS TEST PERFORMED THAT DAY SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=1746OHMS/IFI=YES. PREVIOUSLY IN (B)(6) 2009, THE PATIENT WAS NOTED TO HAVE BRIEF SEIZURES, THEN 2 PER MONTH OF COMPLEX PARTIAL SEIZURES (CPS) AND 1 TONIC CLONIC SEIZURE ON (B)(6) 2010, AND MULTIPLE SEIZURES WITH CYCLE ON (B)(6) 2012. THE PATIENT STARTED DIAMOX ON THE VISIT DATED (B)(6) 2012. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE MADE BUT NO ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS REFERRED FOR BATTERY REPLACEMENT SURGERY DUE TO THE IFI=YES. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200828

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention