BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3031716 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00895
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 4, 2013
    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 ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THIS DATA INCORRECTLY. DATE OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THIS DATA INCORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD AN INCREASE IN DROP ATTACKS. ATTEMPTS TO CONTACT THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. THE GENERATOR HAS BEEN RETURNED AND IS PENDING PRODUCT ANALYSIS. ACCORDING TO THE PHYSICIAN'S NOTES THE VNS SETTINGS ARE: VNS OUTPUT CURRENT 1.75, ON 30 SECONDS, 1.1 MINUTES OFF. LEAD IMPEDANCE IS OKAY, IFI (INTENSIFIED FOLLOW UP INDICATOR): YES. THE PHYSICIAN STATED THAT THE PATIENT'S SEIZURES CONTROL IS FAIR, BUT HIS VNS GENERATOR NEEDS TO BE REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. PRODUCT ANALYSIS RESULTS WERE PREVIOUSLY REPORTED ON MEDWATCH # 1644487-2013-00877. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. FINAL ELECTRICAL TEST SHOWED A NON-IFI CONDITION AND THE VNS GENERATOR REVEALED THAT 90.589% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134494 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201943

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention