BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2925650 · Received January 22, 2013

    Report

    Report Number
    1644487-2013-00200
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    May 25, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR ON (B)(4) 2013. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. 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 FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR WAS FOUND TO BE AT IFI=YES. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS DISCOVERED THAT THE PATIENT UNDERWENT GENERATOR REVISION SURGERY THAT DAY. THE PHYSICIAN'S NURSE STATED THAT THE GENERATOR WAS REPLACED BECAUSE 'THE BATTERY WAS LOW'. THE NURSE DID NOT KNOW WHETHER AN IFI/NEOS/EOS MESSAGE WAS OBSERVED AND STATED THAT THE PHYSICIAN DOES NOT WRITE IT DOWN, HE ONLY SAYS THAT THE BATTERY IS LOW. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6), 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2012 INDICATED THAT THE STAFF FEELS THE PATIENT'S SEIZURES ARE WORSE WITH THE LAST VNS ADJUSTMENT. CLINIC NOTES DATED (B)(6) 2012 INDICATED THAT THE STAFF REPORTS THAT THE PATIENT IS DOING WORSE. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31245 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other