BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC STIMULATOR

    MDR report key: 14518103 · Received May 26, 2022

    Report

    Report Number
    2134265-2022-06074
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 3, 2022
    Report Date
    September 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    A SITE VISIT WAS PERFORMED BY A BOSTON SCIENTIFIC REPRESENTATIVE TO REPAIR THE SYSTEM. THE STIMCOR PC WAS REPLACED WITH A NEW STIMLAB COMPUTER CABINET. THE SYSTEM HAS BEEN CONFIGURED FOR USE. A SAFETY EVALUATION WAS PERFORMED SUCCESSFULLY, AND THE SYSTEM IS READY TO BE USED. 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.

    Additional Manufacturer Narrative · 0

    A SITE VISIT WAS PERFORMED BY A BOSTON SCIENTIFIC REPRESENTATIVE TO REPAIR THE SYSTEM. THE STIMCOR PC WAS REPLACED WITH A NEW STIMLAB COMPUTER CABINET. THE SYSTEM HAS BEEN CONFIGURED FOR USE. A SAFETY EVALUATION WAS PERFORMED SUCCESSFULLY, AND THE SYSTEM IS READY TO BE USED. THE MICROPACE STIMLAB GENERATOR WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE RETURNED GENERATOR UNDERWENT A VISUAL INSPECTION. THE STIMULUS GENERATOR WAS VISUALLY DAMAGED NEAR THE CABLE CONNECTION POINTS. ALONG WITH THE FIELD INFORMATION NOTING REPLACEMENT OF THE GENERATOR RESOLVED THE ISSUE, ANALYSIS OF THE DEVICE CONFIRMED THE REPORTED CLINICAL OBSERVATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREPARATION FOR A PROCEDURE, THE STIMULUS GENERATOR WAS NOT PROCESSING PAST THE START SCREEN, AN ERROR MESSAGE WAS DISPLAYED. IT WAS LATER CONFIRMED THAT THE ISSUE WAS CAUSED BY A FAILED BONALITE PC. THE PATIENT WAS UNDER GENERAL ANAESTHESIA AND CATHETERS ALREADY IN THE HEART WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREPARATION FOR A PROCEDURE, THE STIMULUS GENERATOR WAS NOT PROCESSING PAST THE START SCREEN, AN ERROR MESSAGE WAS DISPLAYED. IT WAS LATER CONFIRMED THAT THE ISSUE WAS CAUSED BY A FAILED BONALITE PC. THE PATIENT WAS UNDER GENERAL ANAESTHESIA AND CATHETERS ALREADY IN THE HEART WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREPARATION FOR A PROCEDURE, THE STIMULUS GENERATOR WAS NOT PROCESSING PAST THE START SCREEN, AN ERROR MESSAGE WAS DISPLAYED. IT WAS LATER CONFIRMED THAT THE ISSUE WAS CAUSED BY A FAILED BONALITE PC. THE PATIENT WAS UNDER GENERAL ANAESTHESIA AND CATHETERS ALREADY IN THE HEART WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763440 CARDIAC STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ BOSTON SCIENTIFIC CORPORATION 86650 OEMTRACE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown