BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 20247086 · Received September 18, 2024

    Report

    Report Number
    1644487-2024-01183
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 14, 2024
    Report Date
    December 26, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    THE PATIENT LATER HAD A PROPHYLACTIC BATTERY REPLACEMENT. THE EXPLANT FACILITY HAS REPORTED THAT THE DEVICE WAS NOT RECEIVED INTO PATHOLOGY. IT IS ASSUMED TO HAVE BEEN DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING DISCOMFORT FROM THE LEAD. PATIENT IS REFERRED FOR A PROPHYLACTIC BATTERY REPLACEMENT WITH NOTE FOR SURGEON TO INSPECT THE LEAD. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PHYSICIAN HAS RESPONDED THAT THE REFERRAL FOR SURGEON TO INSPECT THE LEAD WAS NOT TO PRECLUDE SERIOUS INJURY, IT WAS FOR PATIENT COMFORT ONLY AND THAT THE CAUSE OF THE LEAD DISCOMFORT IS DUE TO LOW BATTERY. (*THIS IS NOT POSSIBLE AND IT IS ASSUMED THAT A CLERICAL ERROR WAS MADE WHILE FILLING OUT THE GFA RESPONSES. THE PHYSICIAN WAS CONTACTED FOR CLARITY ON HIS RESPONSE.) THE PHYSICIAN LATER RESPONDED THAT THERE IS NO LEAD DISCOMFORT, THAT PATIENT IS NERVOUS IT IS NOT WORKING DUE TO BREAK THROUGH SEIZURES. THE PATIENT IS REFERRED FOR BATTERY REPLACEMENT DUE TO LOW BATTERY WITH NEUROLOGIST REQUEST FOR SURGEON TO INSPECT THE LEAD DUE TO PATIENT BEING NERVOUS IT IS NOT WORKING DUE TO BREAK THROUGH SEIZURES. LEAD IMPEDANCE IS NORMAL SO THERE IS NO REASON TO SUSPECT A LEAD MALFUNCTION. THE SUSPECT DEVICE WILL BE MOVED TO THE GENERATOR. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384591 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 204262 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention