BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2970839 · Received February 20, 2013

    Report

    Report Number
    1644487-2013-00462
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED ON (B)(4) 2013 AND IT WAS FOUND TO BE AND IFI (INTENSIFIED FOLLOW-UP INDICATOR) CONDITION. 92% OF THE BATTERY WAS CONSUMED AND THERE WERE NO PERFORMANCE ISSUES FOUND WITH THE PULSE GENERATOR. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN STATING THAT THE PATIENT¿S SEIZURES HAVE IMPROVED AFTER THE VNS GENERATOR REPLACEMENT AND MEDICATIONS WERE STABILIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MOTHER CALLED THE AMBULANCE BECAUSE THE PATIENT HAD INCREASE IN SEIZURES. THE PATIENT'S OUTPUT CURRENT WAS INCREASED FROM 2.25MA TO 2.5MA AND THE PATIENT STARTED TO COUGH AFTER THE INTENSIFIED FOLLOW-UP INDICATOR (IFI) WAS OBSERVED. THE PHYSICIAN INDICATED THAT THE SETTINGS WERE OUTPUT CURRENT= 2.25 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 500 SEC/ON TIME= 30 SEC/OFF TIME= 1.1 MIN / MAGNET OUTPUT CURRENT= 250 MA/ ON TIME= 60 SEC/ PULSE WIDTH= 500 SEC. AND DIAGNOSTICS WERE OUTPUT=OK/LEAD IMPEDANCE=2355 OHMS/IFI YES. THE PHYSICIAN WAS CONTACTED AND HE STATED THAT THE INCREASE IN SEIZURES WAS DUE TO THE BATTERY'S END OF LIFE. ACCORDING TO THE DIAGNOSTICS ON (B)(6) 2013 THE GENERATOR WAS NOT AT EOS. THE PATIENT HAD HIS VNS GENERATOR REPLACED ON (B)(6) 2013. ATTEMPTS TO RETURN THE EXPLANTED GENERATOR IS UNDERWAY.

    Description of Event or Problem · 1

    THE VNS GENERATOR WAS RECEIVED TO THE MANUFACTURER ON (B)(4) 2013. PRODUCT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74309 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201195

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization