BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 21827639 · Received April 11, 2025

    Report

    Report Number
    1644487-2025-10029
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 17, 2025
    Report Date
    November 21, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 CFR 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.

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT; CORRECTED INFORMATION, INITIAL REPORT INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION D6B. IF EXPLANTED, GIVE DATE; CORRECTED INFORMATION, INITIAL REPORT INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION H6. HEALTH EFFECT - IMPACT CODE; CORRECTED INFORMATION, INITIAL REPORT INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION H6. TYPE OF INVESTIGATION; CORRECTED INFORMATION, INITIAL REPORT INADVERTENTLY OMITTED INFORMATION KNOWN PRIOR TO SUBMISSION.

    Additional Manufacturer Narrative · 0

    B5, CORRECTED DATA: INITIAL REPORT INADVERTENTLY OMITTED INFORMATION REGARDING THE ASSOCIATED PREMATURE DEPLETION INFORMATION. D3, CORRECTED DATA: THE INITIAL AND SUPPLEMENTAL #1 REPORTS INADVERTENTLY OMITTED CONTACT INFORMATION. G1, CORRECTED DATA: SUPPLEMENTAL #1 AND SUPPLEMENTAL #2 REPORTS INADVERTENTLY OMITTED CONTACT INFORMATION. G3, CORRECTED DATA: SUPPLEMENTAL #1 AND SUPPLEMENTAL #2 REPORTS INADVERTENTLY OMITTED THE DATE RECEIVED BY MANUFACTURER. THIS FIELD HAS BEEN UPDATED TO REFLECT THE INFORMATION RECEIVED FOR THIS CORRECTION REPORT.

    Additional Manufacturer Narrative · 0

    D4. EXPIRATION DATE; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY USED INCORRECT DATE. H4. DEVICE MANUFACTURE DATE; CORRECTED INFORMATION; INITIAL MDR INADVERTENTLY USED INCORRECT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH A HIGH LEAD IMPEDANCE. THE PATIENT FOLLOWED UP FOR SURGERY AND ONLY THE GENERATOR WAS REPLACED. THE PLAN WAS TO REPLACE THE LEAD AT A LATER DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IMPLANT CARD WAS RECEIVED REPORTING THAT THE LEAD WAS REPLACED. THE SUSPECT LEAD HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS ALSO NOTED THAT THE PATIENT'S GENERATOR DEPLETED SOONER THAN EXPECTED. THE REPORTED PREMATURE DEPLETION IS HOUSED UNDER MANUFACTURING NUMBER 1644487-2025-10852. ANY FURTHER INFORMATION RECEIVED REGARDING THE PREMATURE DEPLETION WILL BE REPORTED UNDER MANUFACTURING NUMBER 1644487-2025-10852.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348370 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 3182

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male