BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 22343639 · Received June 27, 2025

    Report

    Report Number
    2182208-2025-03117
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 15, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OSR
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 WHITE SCREEN UNEXPECTED ERROR DIAGNOSTIC MESSAGE COULD NOT BE CONFIRMED. ANALYSIS OF THE SERVICE LOGS FOUND THE CUSTOMER COMMENT THAT THE PRESENTING ELECTROGRAMS (EGM) FOR THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) DID NOT DISPLAY ON THE MOBILE PROGRAMMER APPLICATION EXCEPT FOR THE MARKER CHANNELS WAS 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.

    Additional Manufacturer Narrative · 0

    HEALTH IMPACT F2601. 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 APPLICATION DISPLAYED A WHITE SCREEN UNEXPECTED ERROR DIAGNOSTIC MESSAGE. IT WAS FURTHER REPORTED THAT THE PRESENTING ELECTROGRAMS (EGM) FOR THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) DID NOT DISPLAY ON THE MOBILE PROGRAMMER APPLICATION EXCEPT FOR THE MARKER CHANNELS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802456 CARELINK SMARTSYNC COMMON APP IOS PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS OSR MEDTRONIC, INC. M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown