BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC STIMULATOR

    MDR report key: 18849094 · Received March 6, 2024

    Report

    Report Number
    2124215-2024-13469
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 14, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MICROPACE STIMLAB CARDIAC STIMULATOR SGU WAS EVALUATED BY BOSTON SCIENTIFIC. THE RETURNED SGU DID NOT HAVE ANY ERROR WHEN POWERED ON AND PACE PERFORMED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION OF THE ERROR MESSAGE DISPLAYED. EQUIPMENT WAS FOUND WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH UNKNOWN SEDATION STATUS. IT WAS REPORTED THAT DURING A PROCEDURE, A MICROPACE STIMLAB CARDIAC STIMULATOR SGU WAS SELECTED FOR USE. UNIT DISPLAYS ERROR 47 0 ERROR - SAFETY TEST FAILED. 0A PANEL FAILED. UNIT WAS SHUTDOWN AND REBOOTED SEVERAL TIMES AND ERROR PERSISTED AND WOULD NOT CLEAR. PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS REASON. REPLACEMENT OF THE UNIT AND FIELD SERVICE REQUIRED. IT WAS FURTHER REPORTED THAT THE DEVICE BATCH NUMBER WAS 5623.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH UNKNOWN SEDATION STATUS. IT WAS REPORTED THAT DURING A PROCEDURE, A MICROPACE STIMLAB CARDIAC STIMULATOR SGU WAS SELECTED FOR USE. UNIT DISPLAYS ERROR 47 0 ERROR - SAFETY TEST FAILED. 0A PANEL FAILED. UNIT WAS SHUTDOWN AND REBOOTED SEVERAL TIMES AND ERROR PERSISTED AND WOULD NOT CLEAR. PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS REASON. REPLACEMENT OF THE UNIT AND FIELD SERVICE REQUIRED.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH UNKNOWN SEDATION STATUS. IT WAS REPORTED THAT DURING A PROCEDURE, A MICROPACE STIMLAB CARDIAC STIMULATOR SGU WAS SELECTED FOR USE. UNIT DISPLAYS ERROR 47 0 ERROR: SAFETY TEST FAILED. 0A PANEL FAILED. UNIT WAS SHUTDOWN AND REBOOTED SEVERAL TIMES AND ERROR PERSISTED AND WOULD NOT CLEAR. PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THIS REASON. REPLACEMENT OF THE UNIT AND FIELD SERVICE REQUIRED. IT WAS FURTHER REPORTED THAT THE DEVICE BATCH NUMBER WAS 5623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138489 CARDIAC STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ BOSTON SCIENTIFIC CORPORATION 86650 0000005623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown