BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 11713469 · Received April 23, 2021

    Report

    Report Number
    2124215-2021-06206
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE HEADER NOTED NO ANOMALIES. A REVIEW AT THE DEVICE MEMORY NOTED THAT ON (B)(6) 2020, THE SYSTEM RECORDED CORRUPTION IN THE CALIBRATION CONSTANTS, A WARM RESET AND A BAD OPCODE. THE CALIBRATION CONSTANTS CORRUPT ERROR FORCES THE DEVICE TO COPY A KNOWN GOOD IMAGE OF THE CALIBRATION CONSTANTS FROM FLASH TO RAM. MOST LIKELY THIS WAS DUE TO A SINGLE EVENT UPSET (SEU), THE RESULTING ERROR CORRECTED THE ISSUE. THE DEVICE WAS TAKEN OUT OF SHIP MODE. THE DEVICE WAS PUT THROUGH AND PASSED THE RETURNED PRODUCTS TEST. THIS INVOLVES A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE WARNING MESSAGE OBSERVED IN THE FIELD INDICATING THE DEVICE WAS NOT SAFE TO IMPLANT WAS DUE TO THE CALIBRATION CONSTANT IN MEMORY BEING CORRUPT LIKELY DUE TO SEU. THE CAUSE OF THIS IS NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS NOT IMPLANTED AFTER PRE-IMPLANT INTERROGATION DISPLAYED A WARNING MESSAGE THAT THE DEVICE WAS NOT SAFE TO IMPLANT. THE DEVICE WAS NOT USED AND WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS NOT IMPLANTED AFTER PRE-IMPLANT INTERROGATION DISPLAYED A WARNING MESSAGE THAT THE DEVICE WAS NOT SAFE TO IMPLANT. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613260 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 258589 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1