BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 17526966 · Received August 12, 2023

    Report

    Report Number
    MW5133903
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 20, 2011
    Report Date
    December 6, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RV LEAD WAS IMPLANTED ON (B)(6) 2000. THERE WAS A RED ALERT FOR LOW PACING IMPEDANCE, LESS THAN 200 OHMS. LOW RIGHT VENTRICULAR PACING LEAD IMPEDANCE DETECTED ON (B)(6) 2011. REVIEWED VALUES IN THE PAST WEEK. PATIENT HAS HAD A COUPLE OF NONSUSTAINED EVENTS WHICH WERE APPROPRIATE. THE PHYSICIAN IS DR. (B)(6). HAS BEEN HOVERINA IN THE LOW 200S FOR A WHILE. WAS IN THE 400S 3 YEARS AQO. CANNOT . 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
    870531 MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown