BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 23307788 · Received October 16, 2025

    Report

    Report Number
    2182208-2025-06443
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OSR
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 THERE WERE NO EGMS WAS CONFIRMED. IT WAS ALSO DETERMINED THAT THERE WAS A LOSS OF CONNECTION. ANALYSIS OF THE SERVICE LOGS FOUND THE CUSTOMER COMMENT THAT A DIAGNOSTIC ERROR MESSAGE WAS GENERATED INDICATING THAT THE BATTERIES REQUIRED REPLACEMENT COULD NOT BE CONFIRMED. 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 DURING THE INTERROGATION OF THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) DURING THE PROCEDURE, THERE WERE NO ELECTROGRAMS (EGM) DISPLAYED AS THE FIELD WAS BLACK WHERE THE EGM'S WERE SUPPOSED TO BE DISPLAYED ON THE MOBILE PROGRAMMER APPLICATION. IT WAS NOTED THAT IT WAS THEN NOT POSSIBLE TO MEASURE THE P OR R-WAVES, HOWEVER IMPEDANCE MEASUREMENTS WERE SUCCESSFUL. IT WAS FURTHER NOTED THAT WHEN ATTEMPTING TO USE THE PACING SYSTEM ANALYZER (PSA), A DIAGNOSTIC ERROR MESSAGE WAS GENERATED INDICATING THAT THE BATTERIES REQUIRED REPLACEMENT. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE RESTARTING THE APPLICATION WHICH RESOLVED THE ISSUE. IT WAS DETERMINED DURING ANALYSIS THERE WAS A LOSS OF CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS DETERMINED AT ANALYSIS THAT THERE WAS A LOSS OF CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2737088 CARELINK SMARTSYNC COMMON APP IOS PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS OSR MEDTRONIC, INC. M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown