BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO LEAD

    MDR report key: 23501553 · Received November 7, 2025

    Report

    Report Number
    2649622-2025-31392
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 19, 2024
    Report Date
    April 23, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LWS
    UDI-DI
    00643169451469
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 DEVICE CODES (FDD/ANNEX A):A070910 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

    CONTINUED FROM D10: DTPA2Q1 CRT-D IMPLANTED: (B)(6) 2024 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 FURTHER REPORTED THAT THE RV LEAD CONTINUED TO EXHIBIT INTERMITTENT UNDERSENSING TRIGGERED FALSE TERMINATION ARRHYTHMIA IN PR OGRESS IN ADDITION TO FLUCTUATING R-WAVE AMPLITUDE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS CHECKED AT THE HOSPITAL DUE TO SUSPECTED LOSS OF CAPTURE, INAPPROPRIATE PACING, AND DELIVERED HIGH VOLTAGE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD CAPTURE WAS UNABLE TO BE CONFIRMED. THE RV LEAD EXHIBITED INTERMITTENT UNDERSENSING PRIOR TO VENTRICULAR FIBRILLATION (VF) DETECTION AND HIGH THRESHOLDS. THE RV 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
    259467 SPRINT QUATTRO LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO VILLALBA 6944-65 00643169451469

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male 5554 LEAD, 4598 LEAD