BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX

    MDR report key: 17530236 · Received August 12, 2023

    Report

    Report Number
    MW5137156
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    April 5, 2021
    Manufacturer
    UNKNOWN
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FROM THE RECORD OF IDENTITY NOTE, IT SEEMED THAT SENSING INTEGRITY COUNTER (SIC) HAS INCREASED MORE THAN BEFORE, BUT IT SEEMED THAT THERE WAS NO OVERSENSING SHOWING SIGNS OF FRACTURE IN PARTICULAR. IN THIS DEVICE CHECK, THE SIC EXCEEDED 18,000 TIMES, IMPEDANCE DROPPED TO 200-2990 HMS, LEAK WAS SUSPECTED. IN ADDITION, OVERSENSING (OS} WAS CONFIRMED DURING THE CHECK AND ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) OF OVERSENSING REMAINED IN THE HIGH-RATE EPISODE, SO LEAD DAMAGE WAS ALMOST CONFIRMED. PATIENT NEEDED TO BE HOSPITALIZED AS A RESULT OF THE EVENT THE ANALYZED PRODUCT NEEDED TO BE RETURNED TO THE CUSTOMER. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727753 LINOX PERMANENT DEFIBRILLATOR ELECTRODES NVY UNKNOWN LINOX SD65 / 18

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown