BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17112843 · Received June 12, 2023

    Report

    Report Number
    2124215-2023-30105
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    December 5, 2022
    Report Date
    August 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE'S DELIVERY OF A SHOCK MAY HAVE CONTRIBUTED TO UNINTENTIONAL INDUCTION OF OR ACCELERATION OF AN ARRHYTHMIA. PLEASE REFER TO THE EVENT TEXT FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE'S DELIVERY OF A SHOCK MAY HAVE CONTRIBUTED TO UNINTENTIONAL INDUCTION OF OR ACCELERATION OF AN ARRHYTHMIA. PLEASE REFER TO THE EVENT TEXT FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. (B)(6) 2023. THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE A CORRECTION/CHANGE FOR THE PATIENT CODES SECTION. CODE E060110 IS THE CORRECT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE. THE SHOCK INDUCED VENTRICULAR FIBRILLATION. ANOTHER SHOCK SUCCESSFULLY CONVERTED THE ARRHYTHMIA. THE DOCTOR IS THINKING ABOUT REPLACING THE SYSTEM. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE A CORRECTION FOR THE PATIENT CODES SECTION. IT WAS REPORTED THAT THE PATIENT HAD AN INAPPROPRIATE SHOCK DUE TO OVERSENSING OF NOISE. THE SHOCK INDUCED VENTRICULAR FIBRILLATION. ANOTHER SHOCK SUCCESSFULLY CONVERTED THE ARRHYTHMIA. THE DOCTOR IS THINKING ABOUT REPLACING THE SYSTEM. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587692 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 159827 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Life Threatening