BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 17528998 · Received August 12, 2023

    Report

    Report Number
    MW5135927
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    December 31, 2021
    Report Date
    March 20, 2022
    Manufacturer
    UNKNOWN
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    I AT/AF EPISODE ON (B)(6) 2021 AT I 0:22. VENTRICULAR OVERSENSING NOTED ON VENTRICULAR PACED BEATS ONLY ON EGM. T WAVE OVERSENSING ON VENTRICULAR PACED BEATS ONLY. UNABLE TO GIVE VERBAL REPORT-CLINICIAN UNAVAILABLE. FYI EMAIL SENT TO ON CALL REP. (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
    2116985 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY UNKNOWN 7122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown