BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC PLATFORM (IOS)

    MDR report key: 21730379 · Received March 31, 2025

    Report

    Report Number
    2182208-2025-01624
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    June 6, 2023
    Report Date
    March 31, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 WHEN ATTEMPTING TO PRESS END SESSION POST IMPLANTABLE DEVICE INTERROGATION THE MOBILE PROGRAMMER APPLICATION FR OZE. IT WAS NOTED THAT THERE WAS CONFIDENCE THAT ALL OF THE INFORMATION FROM THE SESSION HAD BEEN OBTAINED. IT WAS FURTHER NOTED THAT THE ISSUE DID NOT REOCCUR IN ANY OF THE SUBSEQUENT INTERROGATIONS. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041796 CARELINK SMARTSYNC PLATFORM (IOS) ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. M01A01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown