BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 23037605 · Received September 12, 2025

    Report

    Report Number
    1644487-2025-10598
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 12, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 THE PATIENT PRESENTED WITH HIGH IMPEDANCE AND X-RAYS WERE TAKEN. THE X-RAYS WERE RECEIVED AND REVIEWED BY LIVANOVA. THE GENERATOR PLACEMENT WAS LOCATED AT A NORMAL PLACEMENT IN THE UPPER LEFT CHEST PER LABELLING. IT DID NOT APPEAR THAT THE LEAD PIN WAS FULLY INSERTED, HOWEVER DUE TO LOW VISIBILITY OF THE IMAGES THIS COULD NOT BE CONCLUSIVELY CONFIRMED. BASED ON THE IMAGES PROVIDED, THE FEEDTHROUGH WIRES WERE INTACT, HOWEVER IT WAS UNABLE TO BE ASSESSED IF THE PIN WAS FULLY INSERTED AS THE RESOLUTION WAS NOT CLEAR FOR THE FINER DETAILS IN THE IMAGE. THE ENTIRETY OF THE LEAD WAS NOT ABLE TO BE VISUALIZED DUE TO THE QUALITY AND THE SCOPE OF THE IMAGE. THE VISIBLE PORTIONS OF THE PATIENT¿S LEADS APPEARED INTACT, WITH A STRAIN RELIEF BEND PRESENT. HOWEVER, NO TIE DOWNS OR A STRAIN RELIEF LOOP WAS OBSERVED, SO STRAIN RELIEF WAS NOT PLACED PER LABELING. A SHARP ANGLE WAS OBSERVED IN THE LEAD FOLLOWING THE STRAIN RELIEF BEND, WHICH COULD BE CONTRIBUTING TO THE FRACTURE, HOWEVER DUE TO THE QUALITY OF THE IMAGE A FRACTURE AT THAT SHARP ANGLE WAS NOT ABLE TO BE VISUALIZED. THE FIDELITY OF THE LEADS AT THE CONNECTOR PIN COULD NOT BE CONFIRMED DUE TO LOW IMAGE QUALITY. BASED ON THE X-RAYS RECEIVED, THE CAUSE OF THE HIGH IMPEDANCE COULD NOT BE DETERMINED; HOWEVER, ANY FRACTURES OR MICROFRACTURES ON THE PORTIONS OF THE LEAD THAT WERE NOT VISIBLE CANNOT BE RULED OUT. 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
    2365864 LEAD MODEL 302 LEAD LYJ HOUSTON 302-20 201010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female