BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3941921 · Received July 17, 2014

    Report

    Report Number
    1644487-2014-01817
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 23, 2014
    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

    .

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED AN INCREASED SEIZURES AND WAS BEING REFERRED FOR GENERATOR REPLACEMENT DUE TO END OF SERVICE. CLINIC NOTES DATED (B)(6) 2014, NOTE THAT THE PATIENT'S SEIZURES WERE LESS THAN THREE PER YEAR AS OF ONE YEAR AGO. IT IS UNKNOWN WHETHER OR NOT THE INCREASE WAS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. NO KNOWN SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT¿S GENERATOR HAS BEEN REPLACED. A BATTERY LIFE CALCULATION WAS ALSO PERFORMED USING THE PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY FOR THE GENERATOR AND IT WAS FOUND THAT THE DEVICE WAS AT END OF SERVICE AT THE TIME THE SEIZURES WERE OCCURRING THUS ATTRIBUTING THEM TO A LOSS OF THERAPY AS A RESULT OF END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417909 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201194

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention