BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC STIMULATOR

    MDR report key: 18375049 · Received December 21, 2023

    Report

    Report Number
    2124215-2023-72188
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 7, 2023
    Report Date
    April 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROPACE STIMLAB CARDIAC STIMULATOR WAS EVALUATED BY BOSTON SCIENTIFIC. EQUIPMENT FAILED THE VISUAL INSPECTION AS IT PRESENTED A DAMAGED CASE, A MISSING PIN ON VGA CABLE, AND THE REMOTE MONITOR CABLE CUT OFF. A FUNCTIONAL TEST WAS PERFORMED WITH NO SUCCESS; WHEN THE COMPUTER CABINET WAS CONNECTED TO POWER, THE PC WOULD NOT TURN OFF. ONCE CONNECTED TO TOUCHSCREEN, NO SIGNAL WAS DETECTED DUE TO MISSING PIN ON VGA. LABORATORY ANALYSIS WAS ABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION OF FAILURE TO POWER UP WHICH LED TO THE CANCELLATION OF THE PROCEDURE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EVENT WAS CANCELLED/RESCHEDULED WITH UNKNOWN SEDATION STATUS. IT WAS REPORTED THAT A MICROPACE STIMLAB CARDIAC STIMULATOR WAS SELECTED FOR USE. UNIT WAS RECENTLY WORKED ON BY A FIELD SERVICE ENGINEER AND WAS WORKING FINE, HOWEVER, UNIT IS NOW CONTINUOUSLY REBOOTING WHEN POWERED ON MAKING IT IMPOSSIBLE TO PERFORM CASES AND TO TROUBLESHOOT. BAD UNIT IS SUSPECTED. PROCEDURE WAS CANCELLED/ RESCHEDULE. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. A FIELD SERVICE ENGINEER SERVICE WAS LATER PERFORMED. MONITOR FUNCTIONALITY WAS GOOD, BUT THE VGA CABLE CONNECTED FROM STIMLAB WAS MISSING PINS. THE STIMLAB WAS BURNING OUT (SMELT BURNING FROM STIMLAB) PROBABLY DUE TO POWER ISSUES. THE SGU WAS HAVING POWER SUPPLY ISSUES (LOSING POWER MID USE) AS WELL AS THE CONNECTIONS IN THE BACK HAD PINS STUCK IN THEM. THE SERIAL CABLE THAT LEADS TO THE LAB IS DAMAGED THIS ALSO COULD HAVE AFFECTED POWER ISSUE WITH THE STIMBOX. SERIAL CABLE WAS LEFT WITH HOSPITAL FOR CLINICAL ENGINEERING TO RUN A NEW ONE. NEW EQUIPMENT WAS INSTALLED AND IS NOW RUNNING WITHOUT ANY ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EVENT WAS CANCELLED/RESCHEDULED WITH UNKNOWN SEDATION STATUS. IT WAS REPORTED THAT A MICROPACE STIMLAB CARDIAC STIMULATOR WAS SELECTED FOR USE. UNIT WAS RECENTLY WORKED ON BY A FIELD SERVICE ENGINEER AND WAS WORKING FINE, HOWEVER, UNIT IS NOW CONTINUOUSLY REBOOTING WHEN POWERED ON MAKING IT IMPOSSIBLE TO PERFORM CASES AND TO TROUBLESHOOT. BAD UNIT IS SUSPECTED. PROCEDURE WAS CANCELLED/ RESCHEDULE. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. A FIELD SERVICE ENGINEER SERVICE WAS LATER PERFORMED. MONITOR FUNCTIONALITY WAS GOOD, BUT THE VGA CABLE CONNECTED FROM STIMLAB WAS MISSING PINS. THE STIMLAB WAS BURNING OUT (SMELT BURNING FROM STIMLAB) PROBABLY DUE TO POWER ISSUES. THE SGU WAS HAVING POWER SUPPLY ISSUES (LOSING POWER MID USE) AS WELL AS THE CONNECTIONS IN THE BACK HAD PINS STUCK IN THEM. THE SERIAL CABLE THAT LEADS TO THE LAB IS DAMAGED THIS ALSO COULD HAVE AFFECTED POWER ISSUE WITH THE STIMBOX. SERIAL CABLE WAS LEFT WITH HOSPITAL FOR CLINICAL ENGINEERING TO RUN A NEW ONE. NEW EQUIPMENT WAS INSTALLED AND IS NOW RUNNING WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169991 CARDIAC STIMULATOR GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ BOSTON SCIENTIFIC CORPORATION 86650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown