BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK SMARTSYNC BASE

    MDR report key: 14933753 · Received July 6, 2022

    Report

    Report Number
    2182208-2022-02205
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 20, 2022
    Report Date
    September 20, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTC
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    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. ANALYSIS OF THE MOBILE A PPLICATION LOGS INDICATED A USABILITY ISSUE. CONCOMITANT PRODUCT CONTINUED: LEAD 5076-52 LEAD BI SIL STEROID FIX 52 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 MOBILE PROGRAMMER APPLICATION FROZE AND BECAME UNRESPONSIVE WHILE PACING THE PATIENT DURING A PROCEDURE. IT WAS NOTED THAT THE PATIENT WAS SINUS RHYTHM WITH INTERMITTENT HEART BLOCK AND WAS IN P WAVE ASYSTOLE. WHILE SWAPPING BETWEEN LEAD SAFETY PACING AND PERFORMING THRESHOLD CHECKS, THE PATIENT WENT INTO P WAVE ASYSTOLE AND WHEN ATTEMPTING TO PACE ON THE ATRIAL LEAD THERE WAS NO CAPTURE SO PACING ON THE VENTRICULAR LEAD WAS ATTEMPTED, AFTER WHICH IT WAS FURTHER NOTED THAT THE MOBILE PROGRAMMER APPLICATION HAD FROZEN. IT WAS NOTED THAT THE MOBILE PROGRAMMER APPLICATION RESPONDED AFTER A NUMBER OF SECONDS BUT REMAINED SLOW FOR THE REST OF THE PROCEDURE. THE MOBILE PROGRAMMER 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
    2059237 CARELINK SMARTSYNC BASE ANALYZER, PACEMAKER GENERATOR FUNCTION DTC MEDTRONIC, INC. 24970A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention LEAD 5076-58 LEAD BI SIL STEROID FIX 58,