BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 12422353 · Received September 3, 2021

    Report

    Report Number
    1000165971-2021-00631
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    December 16, 2021
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT HAD AN EXTERNAL SHOCK PROCEDURE TO REDUCE AN ATRIAL FIBRILLATION EPISODE IN THE MORNING. AFTER THE SHOCK, THE PATIENT'S RHYTHM INCREASED GRADUALLY UNTIL THE MAX RATE, 130 BPM. THE STIMULATION MODE WAS SAFER-R (RR AUTO, MV+G). THE PHYSICIAN TURNED OFF THE RATE RESPONSE. WHEN THE RATE RESPONSE WAS TURNED ON AGAIN, THE CARDIAC FREQUENCY INCREASED AGAIN. THE PHYSICIAN DID THIS SEVERAL TIMES THEN DECIDED TO LEAVE IT PROGRAMMED OFF. IN THE AFTERNOON, NO ISSUE WAS OBSERVED AND THE PATIENT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAD AN EXTERNAL SHOCK PROCEDURE TO REDUCE AN ATRIAL FIBRILLATION EPISODE IN THE MORNING. AFTER THE SHOCK, THE PATIENT'S RHYTHM INCREASED GRADUALLY UNTIL THE MAX RATE, 130 BPM. THE STIMULATION MODE WAS SAFER-R (RR AUTO, MV+G). THE PHYSICIAN TURNED OFF THE RATE RESPONSE. WHEN THE RATE RESPONSE WAS TURNED ON AGAIN, THE CARDIAC FREQUENCY INCREASED AGAIN. THE PHYSICIAN DID THIS SEVERAL TIMES THEN DECIDED TO LEAVE IT PROGRAMMED OFF. IN THE AFTERNOON, NO ISSUE WAS OBSERVED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319329 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown