BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 17390151 · Received July 25, 2023

    Report

    Report Number
    2124215-2023-39307
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. PLEASE REFER TO B5 DESCRIBE EVENT OR PROBLEM FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT YESTERDAY THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM AND COMPETITOR MICRA PACEMAKER RECEIVED TWO INAPPROPRIATE SHOCKS POSSIBLY DUE TO OVERSENSING. THE PATIENT EXPERIENCED A FEW SECONDS OF DIZZINESS PRIOR TO THE SHOCK. THE PATIENT IS CURRENTLY AN IN-PATIENT WAITING FOR A TRANSPLANT ASSESSMENT. THE S-ICD WAS PROGRAMMED AT 190-250 WHICH WAS APPARENTLY LOWERED POST VENTRICULAR TACHYCARDIA (VT) ABLATION FROM 200. THE S-ICD SYSTEM WAS TURNED OFF FOR NOW, DURING INTERROGATION THE COMPETITOR MICRA PACEMAKER ALSO CONFIRMED WHAT THE S-ICD MORPHOLOGY APPEARED TO LOOK LIKE PACED RHYTHM. LATITUDE PORTABLE DOCUMENT FORMAT (PDF) WERE PROVIDED FOR REVIEW, BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED THE INAPPROPRIATE SHOCKS DUE TO DOUBLE DETECTIONS OF PACED MORPHOLOGY. ALL IMPEDANCES WERE GOOD ACROSS ALL EVENTS. TROUBLESHOOTING OPTIONS WERE RECOMMENDED TO AVOID THE CHARGE FOR LEFT BUNDLE BRANCH BLOCK MORPHOLOGY, THE HEALTHCARE PROFESSIONAL MIGHT WANT TO SAVE A NEW TEMPLATE AND MAX OUT THE SMART CHARGE FEATURE TO A HIGHER THERAPY ZONE. TO BRING THERAPIES EARLIER, 0 EXTENSION SMART CHARGE SHOULD BE KEPT LOW CZ CUT-OFF AND PERHAPS REVIEWING OTHER VECTORS AND HOW OPTIMAL WOULD BE SENSING IN THOSE VECTORS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE AND ELECTRODE REMAIN IN-SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT YESTERDAY THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM AND COMPETITOR MICRA PACEMAKER RECEIVED TWO INAPPROPRIATE SHOCKS POSSIBLY DUE TO OVERSENSING. THE PATIENT EXPERIENCED A FEW SECONDS OF DIZZINESS PRIOR TO THE SHOCK. THE PATIENT IS CURRENTLY AN IN-PATIENT WAITING FOR A TRANSPLANT ASSESSMENT. THE S-ICD WAS PROGRAMMED AT 190-250 WHICH WAS APPARENTLY LOWERED POST VENTRICULAR TACHYCARDIA (VT) ABLATION FROM 200. THE S-ICD SYSTEM WAS TURNED OFF FOR NOW, DURING INTERROGATION THE COMPETITOR MICRA PACEMAKER ALSO CONFIRMED WHAT THE S-ICD MORPHOLOGY APPEARED TO LOOK LIKE PACED RHYTHM. LATITUDE PORTABLE DOCUMENT FORMAT (PDF) WERE PROVIDED FOR REVIEW, BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED THE INAPPROPRIATE SHOCKS DUE TO DOUBLE DETECTIONS OF PACED MORPHOLOGY. ALL IMPEDANCES WERE GOOD ACROSS ALL EVENTS. TROUBLESHOOTING OPTIONS WERE RECOMMENDED TO AVOID THE CHARGE FOR LEFT BUNDLE BRANCH BLOCK MORPHOLOGY, THE HEALTHCARE PROFESSIONAL MIGHT WANT TO SAVE A NEW TEMPLATE AND MAX OUT THE SMART CHARGE FEATURE TO A HIGHER THERAPY ZONE. TO BRING THERAPIES EARLIER, 0 EXTENSION SMART CHARGE SHOULD BE KEPT LOW CZ CUT-OFF AND PERHAPS REVIEWING OTHER VECTORS AND HOW OPTIMAL WOULD BE SENSING IN THOSE VECTORS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE AND ELECTRODE REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809698 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 253955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| O