BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SMARTSYNC PLATFORM (IOS)

    MDR report key: 13059366 · Received December 22, 2021

    Report

    Report Number
    2182208-2021-05048
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 25, 2021
    Report Date
    January 20, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS REVIEWED. IT WAS REPORTED THERE WAS AN ISSUE WITH THE MOBILE PROGRAMMER USER DISPLAY (INCORRECT DATA). THIS COMPLAINT WAS CONFIRMED BASED ON LOG FILES. THE MOST LIKELY ROOT CAUSE WAS TRACED TO A COMPONENT FAILURE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WAVELET SCORES DISPLAYED BY THE MOBILE PROGRAMMER APPLICATION DID NOT LINE UP WITH THE QRS COMPLEX. IT WAS NOTED THAT DURING THE DEVICE CHECK THE NEXT DAY THAT THE WAVELET SCORES DID NOT LINE UP WITH THE QRS COMPLEX BUT WERE LINED UP ON THE FROZEN STRIP REPORT. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964858 CARELINK SMARTSYNC PLATFORM (IOS) ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. M01A01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male DDPC3D1 IMPLANTABLE CARDIOVERTER DEF, 5076-52 LEAD