BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2792565 · Received October 16, 2012

    Report

    Report Number
    1644487-2012-02630
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED EXPLANT DATE.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED REPORTING THAT A VNS PATIENT WAS HAVING AN INCREASE IN BREAKTHROUGH SEIZURES. THE GENERATOR IS NOTED TO BE 'CRITICALLY LOW IN BATTERY LIFE.' THE PATIENT WAS SEEN ON (B)(6) 2012. THEY WERE LAST SEEN (B)(6) 2012 AND AT THAT TIME HIS SEIZURES HAD BEEN FAIRLY STABLE AVERAGING ABOUT ONE PER MONTH. SINCE HIS LAST VISIT HE ACTUALLY DID EXCELLENT. HOWEVER OVER THE LAST TWO WEEKS HE HAS HAD THREE BREAKTHROUGH SEIZURES AFTER NOT HAVING ANY SEIZURES IN THREE TO FOUR MONTHS. A THOROUGH 10-POINT REVIEW OF SYSTEMS WAS PERFORMED AND WAS SIGNIFICANT FOR SOME AGITATION AND SOME BREAKTHROUGH SEIZURES, BUT OTHERWISE WAS NEGATIVE. THE PATIENT'S VNS WAS INTERROGATED AND SET AT AN OUTPUT CURRENT OF 2 MILLIAMPS, A MAGNET CURRENT OF 2.25 MILLIAMPS, A SIGNAL FREQUENCY OF 30 HERTZ, PULSE WIDTH OF 500, ON TIME WAS 30 SECONDS, OFF TIME 0.8 MINUTES, MAGNET ON TIME WAS 60 SECONDS, MAGNET PULSE WIDTH WAS 500. HIS LEADS WERE INTACT AND IMPEDANCE VALUES WERE NORMAL, BUT IT WAS CRITICALLY LOW IN BATTERY LIFE. THE PATIENT'S SEIZURES WERE OVER THEIR PRE VNS RATE. THEIR GENERATOR WAS RETURNED AND ANALYSIS IS PENDING COMPLETION.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE PATIENT'S EXPLANTED GENERATOR.. RESULTS OF DIAGNOSTIC TESTING AND MONITORING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY IS PARTIALLY DEPLETED, (NEAR IFI) 2.803 VOLTS AS MEASURED DURING COMPLETION OF TEST PARAMETER OF THE FINAL ELECTRICAL TEST. VISUAL INSPECTION RESULTS REVEALED NO EXTERNAL DEVICE ABNORMALITIES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201623

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention