BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2081410 · Received April 22, 2011

    Report

    Report Number
    1644487-2011-00881
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO ERI = YES. NO OTHER ALLEGATIONS AGAINST DEVICE WERE MADE. EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ANALYSIS. UPON ANALYSIS, THE ERI = YES ALLEGATION WAS CONFIRMED. HOWEVER, AN OUT-OF-SPEC CONDITION WAS OBSERVED FOR NUMEROUS TEST PARAMETERS FOLLOWING COMPLETION OF THE AUTOMATED ELECTRICAL TEST. REPLACEMENT OF COMPONENT A3 CORRECTED THE TESTS THAT HAD FAILED, AS A SUCCESSFUL MODULE ELECTRICAL TEST WAS OBTAINED ACCORDING TO FUNCTIONAL SPECIFICATIONS. BASED ON THE PULSE GENERATOR MODULE'S MEASURED BATTERY VOLTAGE OF 2.903V (AS RECEIVED), THE ERI FLAG HAD SET PREMATURELY (ERI TRIP POINT IS 2.62V), DUE TO A SUSPECTED PARAMETRIC SHIFT IN THE COMPONENT A3. RESULTS FROM BOTH FINAL AND MODULE CONFIGURATION AUTOMATED TESTS DEMONSTRATE THAT ALL ATTRIBUTES ASSOCIATED WITH THE OUTPUT WAVEFORM MET SPECIFICATION (PULSE AMPLITUDE, PULSE WIDTH, ETC.). OUTPUT CURRENT REGULATION WAS MAINTAINED, DESPITE THE SLIGHTLY HIGH DC-STEP AMPLITUDES. THEREFORE, IT IS HIGHLY LIKELY THE GENERATOR OUTPUT CURRENT MET SPECIFICATIONS DURING ITS IMPLANT LIFE. THE FAILURE MECHANISM FOR THE COMPONENT A3 WAS NOT ASCERTAINED. NO OTHER ANOMALIES WERE NOTED FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011989

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR