BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARELINK SMARTSYNC COMMON APP IOS

    MDR report key: 21419798 · Received February 20, 2025

    Report

    Report Number
    2182208-2025-00905
    Event Type
    Death
    Date Received
    February 20, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 15, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION FDC CODE H6 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 DATA/DATABASE FOUND THE CUSTOMER COMMENT THAT THE MOBILE PROGRAMMER APPLICATION PROMPTED THAT AN UPDATE WAS REQUIRED WAS CONFIRMED. ANALYSIS OF THE DATA/DATABASE FOUND THE CUSTOMER COMMENT THAT THE UPDATE TOOK LONGER THAN EXPECTED 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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 MOBILE PROGRAMMER APPLICATION PROMPTED THAT AN UPDATE WAS REQUIRED WHEN ATTEMPTING TO INTERROGATE A PATIENT THAT WAS "CODING". THE UPDATE WAS INITIATED, HOWEVER THE UPDATE WAS TAKING LONGER THAN EXPECTED RESULTING IN THE NECESSITY TO SWAP OUT THE MOBILE PROGRAMMER APPLICATION. THE INTERROGATION WAS THEN SUCCESSFULLY COMPLETED WITH THE REPLACEMENT MOBILE PROGRAMMER APPLICATION, HOWEVER THE PATIENT SUBSEQUENTLY PASSED AWAY. IT WAS REPORTED THAT THE PATIENT DEATH WAS NOT DUE TO THE APPLICATION UPDATE. IT WAS NOTED THAT DISSATISFACTION WAS EXPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424734 CARELINK SMARTSYNC COMMON APP IOS ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. M01A02

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| D