BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17773631 · Received September 19, 2023

    Report

    Report Number
    1644487-2023-01353
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    March 28, 2023
    Report Date
    September 19, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR COULD NOT BE INTERROGATED. IT HAD BEEN INTERROGATED A FEW MONTHS PRIOR WITH NO ISSUE. THERE WERE NO KNOWN EXTERNAL INFLUENCES OR EVENTS THAT COULD HAVE IMPACTED THE GENERATOR'S FUNCTION. TROUBLESHOOTING STEPS WERE TAKEN TO REDUCE ELECTRO-MAGNETIC INTERFERENCE (EMI), ENSURING THE WAND IS PLACED DIRECTLY OVER THE GENERATOR, CHECKING WAND POWER, REPLACING BATTERIES IF NEEDED, VERIFYING THE WAND SELECTION ON THE TABLET, AND CONNECTING WITH USB CABLE, ALL TO NO AVAIL. THE PATIENT LATER UNDERWENT A BATTERY REPLACEMENT DUE TO FAILURE TO PROGRAM THAT WAS THOUGHT TO BE ASSOCIATED WITH A DEPLETED BATTERY. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER TO UNDERGO PRODUCT ANALYSIS. PRODUCT ANALYSIS OF THE CRYSTAL FROM THE RETURNED PULSE GENERATOR PCBA WAS PERFORMED. THE GENERATOR HAD COMMUNICATION ISSUES WHEN AN INTERROGATION AND A SYSTEM DIAGNOSTIC TEST WERE PERFORMED, AS RECEIVED. HOWEVER, THE DEVICE DID COMMUNICATE THE NEXT DAY AFTER LEAVING IT OVERNIGHT AT THE PRODUCT ANALYSIS (PA) BENCH. VISUAL ANALYSIS OF THE DEVICE REVEALED THAT RESIDUES FROM THE SMT AND BATTERY ATTACH PROCESS ON MULTIPLE LOCATIONS, INCLUDING WHERE THE PCBA CRYSTAL WAS LOCATED. THE CRYSTAL WAS PLACED ON A KNOWN, FUNCTIONAL BENCH M106 GENERATOR PCBA THAT COMMUNICATES. THIS BENCH PCBA WAS SET TO 3 VOLTS BUT WOULD NOT INTERROGATE. THIS INDICATED THAT THE CRYSTAL WAS NOT FUNCTIONAL. IT IS ALSO SUSPECTED THAT THE HEAT TO REMOVE THE CRYSTAL FROM THE GENERATOR MAY HAVE CONTRIBUTED TO ITS FINAL DEMISE. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE PULSE GENERATOR. THE DEVICE PASSED ALL SPECIFICATIONS, INCLUDING QUALITY CONTROL INSPECTION, AND SHOWED NO NON-CONFORMITIES PRIOR TO ITS RELEASE INTO THE FIELD FOR DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595408 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 205511 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female