BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC STIMULATOR

    MDR report key: 15095171 · Received July 25, 2022

    Report

    Report Number
    2124215-2022-27198
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ON SITE REPAIR WAS PERFORMED AND THE SYSTEM WAS TESTED WITH DIFFERENT OPTIONS AND IT WAS NOT POSSIBLE TO DUPLICATE THE PROBLEM. THE SGU SENSE WAS CHANGE TO DIFFERENT LEADS AND IT WAS POSSIBLE TO SE THE SIGNALS. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, A MICROPACE STIMLAB CARDIAC STIMULATOR (SGU) WAS SELECTED FOR USE. DURING THE PROCEDURE A SUPRAVENTRICULAR TACHYCARDIA ABLATION WAS LIMITED SINCE THERE WAS NO ELECTROCARDIOGRAM (ECG) SIGNALS VISIBLE, AND IT WAS STATED THAT "THEY COULD NOT PVC ON THE HIST, AND IT LIMITED THE CASE DURING SVT ABLATION". THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356111 CARDIAC STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ BOSTON SCIENTIFIC CORPORATION 86650 18-466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown