BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 21019328 · Received December 26, 2024

    Report

    Report Number
    2649622-2024-34937
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 9, 2024
    Report Date
    December 26, 2024
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169356559
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 97715 NEUROMODULATION IPG IMPLANTED: (B)(6) 2023 977A260 NEUROMODULATION LEAD IMPLANTED: (B)(6) 2023 977A260 NEUROMODULATION LEAD IMPLANTED: (B)(6) 2023. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN AUDIBLE ALERT FOR LOW PACING IMPEDANCE. THE AUDIBLE ALERTS WERE TURNED OFF AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436090 SPRINT QUATTRO SECURE S MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 6935M55 00643169356559

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male DDMB1D4 ICD, 407645 LEAD