BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 16069798 · Received December 29, 2022

    Report

    Report Number
    1644487-2022-01679
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 29, 2022
    Report Date
    March 17, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT PATIENT IMPLANTED RECENTLY AND WAS SEEN WITH A ¿LOW IMPEDANCE¿ ERROR. X-RAYS WERE TAKEN AS A RESULT. THE X-RAYS WERE REVIEWED BY THE MANUFACTURER BASED ON THE X-RAYS RECEIVED, THE CAUSE OF THE LOW IMPEDANCE CANNOT BE DETERMINED. THE VISIBLE PORTIONS OF THE DEVICE SEEM TO SHOW NO ANOMALIES; HOWEVER, ANY FRACTURES OR MICROFRACTURES ON THE PORTIONS OF THE LEAD THAT WERE NOT VISIBLE CANNOT BE RULED OUT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    LOW IMPEDANCE WAS RESOLVED SPONTANEOUSLY. IMPEDANCE TESTED OKAY AFTER NO INTERVENTION TAKEN. IT WAS NOTED THAT THE LOW IMPEDANCE WAS NOT SEEN EVERY TIME AN INTERROGATION WAS SEEN SPORADICALLY. GENERATOR DATA WAS REVIEWED IN WHICH NO OBVIOUS GENERATOR ISSUES WERE IDENTIFIED. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE LEAD PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GENERATOR WAS RESET. THIS DID NOT RESOLVE THE LOW IMPEDANCE, NOR WERE ANY NEW ERROR MESSAGES VISUALIZED. LOW IMPEDANCE REMAINS FLUCTUATING AS SEEN BY SESSION REPORTS. THIS COULD BE INDICATIVE OF A LEAD RELATED ISSUE. X-RAYS ARE REFERRED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767218 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 205767 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female