BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3031670 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00877
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURES AND HIS GENERATOR HAS BEEN REPLACED ON (B)(6) 2013. THE MOTHER REPORTED TO THE PHYSICIAN THAT THE PATIENT HAD A CLUSTER OF SEIZURES WITH 2-3 SEIZURES PER NIGHT LASTING A MINUTE EACH. PREVIOUS INCREASE IN SEIZURES WAS RELATED TO INFECTIONS THAT EXACERBATED THE SEIZURES. ATTEMPTS TO CONTACT THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. THE PRODUCT WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2013. 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

    PRODUCT ANALYSIS ON THE RETURNED VNS GENERATOR WAS PERFORMED. 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
    135156 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201943

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention