BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 5788469 · Received July 12, 2016

    Report

    Report Number
    1644487-2016-01570
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 17, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS LATER RECEIVED CONFIRMING THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2016 DUE TO PROPHYLACTIC REPLACEMENT DUE TO IFI = YES. AFTER REPLACEMENT, THE NEW IMPEDANCE VALUE WAS FOUND TO BE OK AT 2533 OHMS, WHICH IS WITHIN NORMAL LIMITS. IT WAS LATER REPORTED BY THE PHYSICIAN THAT THE PATIENT'S INCREASE IN SEIZURES WAS AT HIS PRE-VNS BASELINE LEVEL AND THAT NO TRAUMA, MEDICATION CHANGE, OR EXTERNAL STRESSOR CAUSED OR CONTRIBUTED TO THE INCREASE IN SEIZURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTED THAT THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT AS HIS GENERATOR BATTERY WAS AT END OF LIFE AND THE PATIENT'S SEIZURE FREQUENCY HAD BEEN INCREASING, PRESUMABLY RELATED TO THE END OF THE BATTERY LIFE. HOWEVER, IT WAS LATER NOTED IN CLINIC NOTES THAT DEVICE DIAGNOSTICS WERE PERFORMED AND SHOWED THE IMPEDANCE WAS WITHIN NORMAL LIMITS WITH A VALUE OF 2609 OHMS AND AN IFI = YES (INTENSIFIED FOLLOW-UP INDICATOR). THE IFI = YES CONDITION VERIFIES THE VNS GENERATOR SHOULD HAVE STILL BEEN DELIVERING THERAPY AS INTENDED. A BATTERY LIFE CALCULATION WAS PERFORMED SHOWING THE GENERATOR HAD APPROXIMATELY 0.4 YEARS REMAINING UNTIL NEOS = YES (NEAR END OF SERVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439449 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202954

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR