BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 21697651 · Received March 26, 2025

    Report

    Report Number
    1644487-2025-00331
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    November 1, 2023
    Report Date
    May 6, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750047
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿MIGRATION¿ IS NOT AVAILABLE. (NOTE THAT ALTHOUGH MIGRATION IS AN AVAILABLE MEDICAL DEVICE PROBLEM CODE, IN THIS REPORT¿S CONTEXT, THE MIGRATION DOES NOT REFLECT A PROBLEM WITH THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. THEREFORE, A DEVICE PROBLEM CODE DOES NOT ADEQUATELY CAPTURE THE PATIENT¿S ADVERSE EVENT.) H3. DEVICE EVALUATED BY MFR? CODE 81 - DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED AS NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.

    Description of Event or Problem · 0

    IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT SHE FELT HER GENERATOR "FLIP" IN HER CHEST BACK IN (B)(6) 2023 AND HAS BEEN EXPIRING DAILY PAIN EVER SINCE. THE PAIN HAS SINCE GOTTEN WORSE, 6.5/10 PAIN LEVEL, AND THE PATIENT IS TREATING THE PAIN WITH OVER-THE-COUNTER MEDICATION(TYLENOL/MOTRIN) AND ALSO USING A HEATING PAD. THE PATIENT ATTRIBUTES HER PAIN TO BE DUE TO SCAR TISSUE AND LOW BATTERY. THE PATIENT HAS SINCE BEEN REFERRED FOR A BATTERY REPLACEMENT. NO KNOWN 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
    1694789 PULSE GEN MODEL 104 GENERATOR LYJ LIVANOVA USA, INC. 104 204167 05425025750047

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other