BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 24966980 · Received April 23, 2026

    Report

    Report Number
    2649622-2026-11571
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    NVY
    UDI-DI
    00643169082281
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 EXHIBITED HIGH THRESHOLD MEASUREMENTS. THE LEAD WAS CUT FOR LASER LEAD EXTRACTION BUT WAS UNSUCCESSFUL. IT WAS NOTED THAT JUST THE END OF THE LEAD WAS CUT OFF AND MOST OF THE LEAD REMAINS IN THE BODY CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600789 SPRINT QUATTRO SECURE MRI SURESCAN PERMANENT DEFIBRILLATOR ELECTRODES NVY MEDTRONIC PUERTO RICO VILLALBA 6947M72 00643169082281

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization| R DVFB1D4 ICD.