BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 21510778 · Received March 3, 2025

    Report

    Report Number
    1028232-2025-01116
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 12, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES. THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    COMBINATION PRODUCT: YES.

    Description of Event or Problem · 0

    REMOTE MONITORING REPORTED HIGH SHOCK IMPEDANCE >100 OHM. LAST VALUE MEASURED 128 OHM. SHOCK IMPEDANCE APPEARS TO TREND BETWEEN 100-125 OHMS WITH ABRUPT INCREASES IN THE PAST. ALL OTHER LEAD TRENDS APPEAR STABLE AND NO NOISE ON RECORDINGS. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777856 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female