BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 13764144 · Received March 14, 2022

    Report

    Report Number
    1644487-2022-00274
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 17, 2022
    Report Date
    July 15, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN EATING NORMALLY, WAS MORE AGITATED COUGHING AND EXPERIENCING AN INCREASE IN SEIZURES. WHEN THE PATIENT WAS SEEN IN CLINIC TO HAVE THEIR OUTPUT CURRENT LOWERED FROM 0.75MA TO 0.5MA, LOW OUTPUT CURRENT WAS OBSERVED. THE PATIENT HAD A CHEST X-RAY DONE AND HAS SINCE BEEN REFERRED FOR A FULL REVISION. THE MANUFACTURER'S DEVICE HISTORY RECORDS WERE REVIEWED. THE GENERATOR PASSED FINAL FUNCTIONAL AND QUALITY SPECIFICATIONS PRIOR TO RELEASE NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION OBTAINED NOTING THAT THE PATIENT UNDERWENT SURGERY AND THE SURGEON TRIED TO REINSERT THE LEAD PIN BUT THIS DID NOT RESOLVE THE ISSUE THEREFORE THE GENERATOR WAS REPLACED AND ALL DIAGNOSTIC VALUES WERE WITHIN NORMAL LIMITS. THE EXPLANTED GENERATOR WAS RETURNED BUT PRODUCT ANALYSIS IS STILL UNDERWAY.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED AND APPROVED FOR THE RETURNED GENERATOR. THE ELECTRICAL TESTS PERFORMED IN THE PA LAB FOUND THAT THE GENERATOR WAS AT AN IFI = NO CONDITION. THE BATTERY VOLTAGE WAS MEASURED AT 2.940 VOLTS. THE REPORTED LOW OUTPUT CURRENT WAS DUPLICATED IN THE PA LAB. PROGRAMMED THE PULSE GENERATOR OUTPUT CURRENT TO 1.00MA. PERFORMED A SYSTEM DIAGNOSTIC TEST, THE LEAD IMPEDANCE RESULTS WERE 4000/<=600 AND NO OUTPUT WAVEFORM WAS OBSERVED ON THE PA BENCH OSCILLOSCOPE. THEREFORE, THE DEVICE OUTPUT SIGNAL WAS NOT MONITORED FOR MORE THAN 24-HRS DUE TO NO OUTPUT SIGNAL FROM THE PULSE GENERATOR. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR DID NOT PERFORM ACCORDING TO FUNCTIONAL SPECIFICATIONS DUE THE REED SWITCH BEING CLOSED. ALL FAILED FET TEST PARAMETERS ARE RELATED TO THE REED SWITCH. A MAGNET WAS APPLIED NUMEROUS TIMES TO THE REED SWITCH, LEFT OVER THE REED SWITCH FOR VARIOUS TIME INTERVALS (UP TO TEN MINUTES), IN ATTEMPT TO GET THE REED SWITCH TO REMAIN CLOSED, AS RECEIVED, WHEN THE MAGNET IS REMOVED FROM THE REED SWITCH. COULD NOT REPLICATE THE REED SWITCH REMAINING STUCK CLOSED, AS RECEIVED, WHEN THE MAGNET WAS REMOVED FROM THE REED SWITCH. THE CAUSE FOR THE PULSE GENERATOR TO HAVE NO OUTPUT SIGNAL WAS DETERMINED TO BE THE REED SWITCH BEING STUCK IN A CLOSED CONDITION. THE REED SWITCH STUCK IN A CLOSED CONDITION MAY HAVE BEEN THE CONTRIBUTING FACTOR FOR THE ALLEGATIONS OF ¿ENERGY OUTPUT TO PATIENT TISSUE INCORRECT¿ AND ¿OUTPUT CURRENT LOW¿. THE FAILURE MECHANISM FOR THE CLOSED REED SWITCH CONDITION IS RELATED TO THE MATERIAL USED TO MAKE THE REED SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28899 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205765 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention