BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 15752290 · Received November 8, 2022

    Report

    Report Number
    1644487-2022-01410
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    May 1, 2022
    Report Date
    November 8, 2022
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    PATIENT WAS SCHEDULED TO UNDERGO A BATTERY REPLACEMENT AND THEN IT WAS FOUND THAT THEY HAD HIGH IMPEDANCE IN PRE-OP, 7,000 OHMS, WHICH WAS NOT KNOWN PREVIOUSLY BY THE SURGEON OR REP SO THEY WERE NOT PREPARED TO DO A FULL REVISION. X-RAYS WERE PERFORMED AND NO ANOMALIES WERE OBSERVED. THE PATIENT UNDERWENT SURGERY AND HAD THEIR BATTERY ONLY REPLACED AND THERE WAS TWO CLEAR BREAKS OBSERVED IN THE LEAD. THE SURGEON DECIDED TO PLACE A FACET AROUND THE FRACTURES AND DECIDED TO TURN THE PATIENT'S DEVICE ON DESPITE THE REPS RECOMMENDATIONS TO LEAVE IT OFF DUE TO THE HIGH IMPEDANCE SEEN. THE IMPEDANCE REMAINED HIGH, AS EXPECTED, WITH THE NEW GENERATOR (9,000 OHMS). THROUGH FOLLOW-UP IT WAS DETERMINED THAT HIGH IMPEDANCE WAS FIRST OBSERVED IN SEPTEMBER BY THE PATIENT'S NEURO BUT THIS INFORMATION WAS NEVER RELAYED AND THE PATIENT WAS INITIALLY REFERRED FOR A REPLACEMENT BACK IN MAY DUE TO NOT FEELING STIMULATION AS STRONG ANYMORE. THE PATIENT THEN LATER UNDERWENT A LEAD REVISION. THE EXPLANTED DEVICES WERE NOT MADE AVAILABLE FOR RETURN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250770 LEAD MODEL 304 LEAD LYJ CYBERONICS - HOUSTON 304-20 2658

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female