BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 8764620 · Received July 5, 2019

    Report

    Report Number
    1644487-2019-01295
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 7, 2018
    Report Date
    August 16, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS EXPLANTED, NOT RELATED TO DEVICE BATTERY LIFE PREVIOUSLY REPORTED. THE EXPLANTING FACILITY DOES NOT RETURN EXPLANTED PRODUCTS TO MANUFACTURERS; THEREFORE, RETURN OF THE SUSPECT PRODUCT IS NOT EXPECTED TO DATE. AN OHM'S LAW CALCULATION WAS PERFORMED WHICH INDICATED THAT THE DEVICE SHOULD HAVE BEEN ABLE TO DELIVER THE PROGRAMMED OUTPUT CURRENT WITH THE GIVEN LEAD IMPEDANCE AND NORMAL DEVICE VARIATION IN IMPEDANCE ACCURACY AND MAXIMUM OUTPUT VOLTAGE. THE INTERNAL DATA OF THE PATIENT'S GENERATOR WAS REVIEWED. THE LAST BATTERY STATUS INDICATOR SHOWED THAT THE GENERATOR HAD 25% BATTERY REMAINING AND THE CAPACITY OF THE BATTERY CONSUMED WAS 63.449%. THERE IS A SLIGHT DISCREPANCY BETWEEN THE BATTERY PERCENTAGE REMAINING AND THE CAPACITY USED. ON THE DATE THAT LOW OUTPUT CURRENT WAS SEEN; THE PEAK OUTPUT CURRENT WAS INDICATED AS 3.25MA DESPITE PROGRAMMED TO 3.5MA. NO OTHER ANOMALIES WERE IDENTIFIED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR BATTERY INDICATED LESS THAN 25% CAPACITY REMAINING. THE REPRESENTATIVE WANTED TO KNOW IF THE BATTERY DEPLETION WAS NORMAL. DURING A REVIEW OF THE INTERNAL DATA OF THE GENERATOR THAT WAS SENT IN, LOW OUTPUT CURRENT WAS IDENTIFIED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE GENERATOR PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS PRIOR TO DISTRIBUTION. BASED ON THE TRIM TEST TAB DATE, THE GENERATOR WAS NOT SUBJECTED TO LASER-ROUTING. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557569 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204201 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR