BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC STIMULATOR

    MDR report key: 11967078 · Received June 9, 2021

    Report

    Report Number
    2134265-2021-07449
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 13, 2021
    Report Date
    February 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. VISUAL INSPECTION DID NOT FIND ANY DEFECTS. THE RETURNED PRODUCT WAS VISUALLY INTACT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    DURING A PROCEDURE A MICROPACE STIMULAION BX WAS SELECTED FOR USE. IT WAS REPORTED THAT THE DEVICE WAS NOT RESPONSIVE. THE DEVICE WAS REBOOTED, HOWEVER, THE UNABLE TO CONNECT ERROR PERSISTED. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    DURING A PROCEDURE A MICROPACE STIMLAB CARDIAC STIMULATOR SGU WAS SELECTED FOR USE. IT WAS REPORTED THAT THE DEVICE WAS NOT RESPONSIVE. THE DEVICE WAS REBOOTED, HOWEVER, THE UNABLE TO CONNECT ERROR PERSISTED. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862926 CARDIAC STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ BOSTON SCIENTIFIC CORPORATION 86650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown