BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3910063 · Received July 2, 2014

    Report

    Report Number
    1644487-2014-01668
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL MANUFACTURER REPORT INADVERTENTLY DID NOT INCLUDE INFORMATION RELEVANT AVAILABLE REGARDING THE INCREASED SEIZURES EVENT REPORTED WHICH HAD BEEN AVAILABLE AT THE TIME THE INITIAL REPORT WAS SUBMITTED. THE CLINIC NOTES ALSO INDICATED THAT THE PATIENT HAS SEVERE SIALORRHEA WHICH IS INTERFERING WITH THE PATIENTS LIFE AND CAUSING SEVERE STRESS AND INCREASE IN THE PATIENT'S SEIZURE ACTIVITY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTED THAT THE PATIENT HAS EXPERIENCED AN INCREASE IN SEIZURES AND THE GENERATOR SHOWED IFI = YES UPON INTERROGATION. IT WAS NOTED THAT THE PATIENT WOULD UNDERGO GENERATOR REPLACEMENT. THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANTING FACILITY DISCARDS EXPLANTED DEVICES DURING SURGERY; THEREFORE, NO ANALYSIS CAN BE PERFORMED. AN IMPLANT CARD WAS RECEIVED THAT NOTED THE GENERATOR WAS EXPLANTED DUE TO BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387191 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201891

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention