BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN LEAD

    MDR report key: 21125409 · Received January 9, 2025

    Report

    Report Number
    MW5164541
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    October 18, 2024
    Report Date
    January 3, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE DEVICE CHECK. DURING THE INTERROGATION, THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS OVERSENSING ATRIAL AND T WAVE SIGNALS. TECHNICAL SERVICE ENGINEER (TSE) WAS CONTACTED AND CONFIRMED WHAT WAS OBSERVED. THE PHYSICIAN DECIDED TO TURN OFF TACHY THERAPY AND ORDERED A CHEST X-RAY. THERE WAS NORMAL CAPTURE THRESHOLD AND IMPEDANCE VALUES WITH CHRONICALLY LOW R WAVE SIGNALS. OF NOTE, THE PATIENT¿S EF HAS RECOVERED TO 50%. AT THE NEXT VISIT, THE DOCTOR WILL DISCUSS LEAVING THE DEVICE OFF PERMANENTLY OR IMPLANTING A NEW RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION INDICATED THAT THE ANOMALY OBSERVED WAS DUE TO THE MEDTRONIC RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS IMPLANTED ON (B)(6) 2012. THE PATIENT¿S CONDITION WAS STABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656538 SPRINT QUATTRO SECURE MRI SURESCAN LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown