BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 22538315 · Received July 17, 2025

    Report

    Report Number
    2649622-2025-19490
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    May 1, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LWS
    UDI-DI
    00643169356566
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, H6 ANNEX D A070102. 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 DISPLAYED A RISE IN PACING IMPEDANCE AND THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS ALSO NOTED THAT THERE WERE HIGH THRESHOLDS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS REPROGRAMMING. IT WAS FURTHER REPORTED THAT THE RV PACING IMPEDANCE CONTINUED TO RISE TO HIGH, TRIGGERING A LEAD WARNING. THERE WAS ALSO INCREASING RV THRESHOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664550 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO VILLALBA 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention 5076-52 LEAD, DDPB3D4 ICD