BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN EL ICD DR

    MDR report key: 20614491 · Received November 5, 2024

    Report

    Report Number
    2124215-2024-69633
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534829
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    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 EXHIBITED OVERSENSING OF NOISE GENERATED BY THE MINUTE VENTILATION (MV)/RESPIRATORY SENSOR THAT IS RELATED TO INTERMITTENT INCREASES IN IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A PRODUCT PERFORMANCE ISSUE OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE SEE THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A SIGNAL ARTIFACT MONITORING (SAM) EPISODE DUE TO OVERSENSING ARTIFACT RELATED TO THE MINUTE VENTILATION (MV) FEATURE SIGNAL ON THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR CHANNEL. IN ADDITION, HIGH OUT OF RANGE PACING IMPEDANCES WERE OBSERVED ON THE SAM EPISODE. THE HIGH OUT OF RANGE IMPEDANCES AND NOISY SIGNALS WERE A RESULT OF A MEDICAL PROCEDURE. THE FEATURE WAS TURNED BACK ON. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A SIGNAL ARTIFACT MONITORING (SAM) EPISODE DUE TO OVERSENSING ARTIFACT RELATED TO THE MINUTE VENTILATION (MV) FEATURE SIGNAL ON THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR CHANNEL. IN ADDITION, HIGH OUT OF RANGE PACING IMPEDANCES WERE OBSERVED ON THE SAM EPISODE. THE HIGH OUT OF RANGE IMPEDANCES AND NOISY SIGNALS WERE A RESULT OF A MEDICAL PROCEDURE. THE FEATURE WAS TURNED BACK ON. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132757 DYNAGEN EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION D153 228232 00802526534829

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female