BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 22282478 · Received June 18, 2025

    Report

    Report Number
    2182208-2025-02953
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 18, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 HEALTHCARE PROVIDER REQUESTED CONFIRMATION THAT A TRANSMISSION WAS SENT FROM THE CARDIAC DEVICE DATA TRANSMISSION APPLICATION FOLLOWING A CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) INTERROGATION. IT WAS NOTED THAT THE HEALTHCARE PROVIDER HAD INADVERTENTLY USED THE MOBILE PROGRAMMER APPLICATION. TECHNICAL SERVICES PROVIDED ASSISTANCE TO INTERROGATE THE CIED USING THE CARDIAC DEVICE DATA TRANSMISSION APPLICATION, WHICH WAS UNSUCCESSFUL AND A DIAGNOSTIC MESSAGE WAS DISPLAYED THAT INDICATED THE APPLICATION WAS SEARCHING FOR THE CIED BUT WAS UNABLE TO PROGRESS FURTHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767509 CARELINK SMARTSYNC COMMON APP IOS ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female