BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 17531951 · Received August 12, 2023

    Report

    Report Number
    MW5138862
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 1, 2021
    Manufacturer
    BIOTRONIK
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PT. HAS A BIOTRONIK LEAD. APPROPRIATES SNUCK DELIVERED. PROGRAMMED TO DELIVER 35J. DELIVERED 24J AND SUCCESSFUL VT CONVERSION. SHOCK IMPEDANCE ZERO. DISCUSSED THAT SHOCK IMPEDANCE LESS THAN 20 J IS ABNORMAL AND SIGNALS A POTENTIAL ISSUE, SUCH AS LEAD INSULATION BREACH. DISCUSSED CHECKING FOR OVERSENSING IN THE TIP TO RVC VECTOR DURING POCKET MA NIP AND ISOMETRICS. THE CONCERN IS THAT IF THERE IS A BREACH, CHARGE CIRCUIT PROTECTION MAY OCCUR, THAT WOULD KEEP THE DELIVERED SHOCK AT 1?2 J TO AVOID DAMAGING THE ICO CIRCUITRY. SHE WILL DISCUSS FINDINGS WITH THE PHYSICIAN. (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
    1355417 LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown