BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SYSTEM

    MDR report key: 22124900 · Received June 2, 2025

    Report

    Report Number
    3017374019-2025-00131
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 2, 2025
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    PMA / PMN Number
    PMA150009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOTRONIK LEAD USED TO CONNECT THE GUARDIAN TO THE HEART WALL DETACHED. THE LEAD IS AN OFF THE SHELF FDA APPROVED DEVICE WHICH IS NOT MANUFACTURED BY AVERTIX MEDICAL INC.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED SEE DR ALERT FOR IRREGULAR HEART RATE MOST LIKELY DUE TO THE POOR SIGNAL ACQUISITION FROM THE DISLODGED CARDIAC LEAD. THE PATIENT HAS A SCHEDULED "LEAD REVISION" TO CORRECT THE PLACEMENT OF THE LEAD. BIOTRONIK S53, SN (B)(6) UPON VISUALIZATION VIA FLUOROSCOPY, IT WAS CONFIRMED BY THE PHYSICIAN (B)(6) 2025 THAT THE PREVIOUSLY PROPERLY PLACED CARDIAC LEAD WAS UNATTACHED TO THE RV AND PULLED BACK NEAR THE TRICUSPID VALVE. IT WAS NOTED PREVIOUSLY, (B)(6), THAT THE SIGNAL FROM THE LEAD TO THE GUARDIAN DEMONSTRATED "NOISE" AND A COMMONLY NOTED WAVEFORM INDICATIVE OF A DISLODGED CARDIAC LEAD. THE PATIENT ENTERED THE PHYSICIAN PRACTICE (B)(6) 2025) NOTING A SEE DR ALERT (B)(6) 2025) FROM THE GUARDIAN AS PER PROTOCOL AND INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719273 GUARDIAN SYSTEM GUARDIAN QBI AVERTIX MEDICAL INC. AMSG3-E

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other