BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 22435253 · Received July 8, 2025

    Report

    Report Number
    2182208-2025-03291
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDTRONIC INC
    Product Code
    OSR
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: PERFORMANCE DATA COLLECTED FROM THE MOBILE PROGRAMMER WAS RECEIVED AND ANALYZED. ANALYSIS OF THE SERVICE LOGS FOUND THE CUSTOMER COMMENT THAT THE MOBILE PROGRAMMER GENERATED A DIAGNOSTIC MESSAGE INDICATING THAT AN UNEXPECTED ERROR HAD OCCURRED COULD NOT BE CONFIRMED. CORRECTION: D.2. PRODUCT CODE COMMON DEVICE NAME. 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 MOBILE PROGRAMMER GENERATED A DIAGNOSTIC MESSAGE INDICATING THAT AN UNEXPECTED ERROR HAD OCCURRED DURING AN INTERROGATION OF THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) WHILE NAVIGATING THROUGH THE E-STRIP ANALYSIS. IT WAS NOTED THAT THE "UP" ARROW WAS PRESSED TO RETURN TO THE INITIAL TRACINGS AFTER SCROLLING ALL THE WAY TO THE TOP OF THE HOLTER E-STRIP WHEN THE ISSUE OCCURRED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE RESTARTING THE APPLICATION WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391533 CARELINK SMARTSYNC COMMON APP IOS PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS OSR MEDTRONIC INC M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female