BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIA MRI CRT-D SURESCAN

    MDR report key: 21069758 · Received January 3, 2025

    Report

    Report Number
    3004209178-2025-00150
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    November 26, 2024
    Report Date
    January 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169929531
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 2187-75 IMPLANTED: (B)(6) 2002. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSEN SING HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE CONFIRMED BY THE CALLER. ADDITIONALLY, IT WAS NOTED THAT THE IMPEDANCE MEASUREMENT WAS NOT TAKEN POSSIBLY DUE TO INTERMITTENT TELEMETRY. THE DEVICE 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
    431363 CLARIA MRI CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMA1D1 00643169929531

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male 6945-65 LEAD, 6940-52 LEAD