BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 13462610 · Received February 4, 2022

    Report

    Report Number
    2124215-2022-03542
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    October 18, 2021
    Report Date
    November 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPERIENCING DIFFICULTY TRANSMITTING A PATIENT INITIATED INTERROGATION (PII) THROUGH THEIR HOME MONITORING SYSTEM. THE PATIENT WAS SEEN IN CLINIC WHERE TROUBLESHOOTING MEASURES WERE TAKEN. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING OPTIONS. A MAGNET RESET WAS PERFORMED AND AFTER THE FOURTH ATTEMPT A SUCCESSFUL MAGNET RESET WAS ACHIEVED, BEEPING TONES WERE AUDIBLE AND THE DEVICE WAS SUCCESSFULLY INTERROGATED. THE PATIENT WAS TO PERFORM A PII WHEN THEY GET HOME. SUBSEQUENTLY, THE PATIENT PERFORMED A PII, BUT STILL EXPERIENCING PROBLEMS. THE PATIENT WAS TO RECEIVE A NEW COMMUNICATOR TO HELP RESOLVE THIS ISSUE. AT THIS TIME, THE DEVICE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED TELEMETRY DIFFICULTY ISSUES WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION; PLEASE REFER TO THE EVENT DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPERIENCING DIFFICULTY TRANSMITTING A PATIENT INITIATED INTERROGATION (PII) THROUGH THEIR HOME MONITORING SYSTEM. THE PATIENT WAS SEEN IN CLINIC WHERE TROUBLESHOOTING MEASURES WERE TAKEN. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING OPTIONS. A MAGNET RESET WAS PERFORMED AND AFTER THE FOURTH ATTEMPT A SUCCESSFUL MAGNET RESET WAS ACHIEVED, BEEPING TONES WERE AUDIBLE AND THE DEVICE WAS SUCCESSFULLY INTERROGATED. THE PATIENT WAS TO PERFORM A PII WHEN THEY GET HOME. SUBSEQUENTLY, THE PATIENT PERFORMED A PII, BUT STILL EXPERIENCING PROBLEMS. THE PATIENT WAS TO RECEIVE A NEW COMMUNICATOR TO HELP RESOLVE THIS ISSUE. AT THIS TIME, THE DEVICE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT TS RECOMMENDED DEVICE REPLACEMENT DUE TO THE INABILITY TO CONSISTENTLY MANAGE THE CARE OF THIS PATIENT, AS THE IN-OFFICE INTERROGATIONS WERE DIFFICULT, AND AT TIMES, IMPOSSIBLE. THIS HAS BEEN GOING ON SINCE NOT LONG AFTER IMPLANT. THIS DIFFICULTY WITH INTERROGATING ALONG WITH THE INABILITY TO BE FOLLOWED ON LATITUDE NXT MAKES THE MANAGEMENT OF THIS PATIENT CARE AT A MINIMUM DIFFICULT, AND AT TIMES, IMPOSSIBLE. AT THIS TIME, THIS S-ICD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386631 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 137478 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male