BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 22358043 · Received June 30, 2025

    Report

    Report Number
    2182208-2025-03154
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 5, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    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 APPLICATION DISPLAYED A DIAGNOSTIC MESSAGE. 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 REMOTE MONITORING APPLICATION WAS UNABLE TO INTERROGATE DUE TO A DIAGNOSTIC ERROR GENERATED INDICATING THAT AN UNEXPECTED ERROR HAD OCCURRED ON THE MOBILE PROGRAMMER APPLICATION. IT WAS NOTED THAT THE DIAGNOSTIC MESSAGE ERROR DESCRIBED WAS A MOBILE PROGRAMMER APPLICATION DIAGNOSTIC MESSAGE, THEREFORE THE MOBILE PROGRAMMER APPLICATION HAD BEEN UTILIZED INSTEAD OF THE REMOTE MONITORING APPLICATION IN ERROR. IT WAS FURTHER NOTED THAT NO CHANGES HAD BEEN MADE TO THE PATIENTS CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) AS THE MOBILE PROGRAMMER APPLICATION WAS UNABLE TO INTERROGATE DUE TO THE DIAGNOSTIC MESSAGE. TROUBLESHOOTING STEPS WERE ADVISED TO RESOLVE 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
    927148 CARELINK SMARTSYNC COMMON APP IOS ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male