BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN CRT-D

    MDR report key: 19703776 · Received July 9, 2024

    Report

    Report Number
    2124215-2024-42236
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 A SIGNAL ARTIFACT MONITOR (SAM) EVENT OCCURRED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RESULTING IN THE RESPIRATORY RATE TREND (RRT) SENSOR BEING DISABLED. TECHNICAL SERVICES (TS) DISCUSSED THE RRT DISABLED DUE TO NOISE WHICH WAS OVERSENSED, DUE TO ELECTROCAUTERY DURING A MEDICAL PROCEDURE THIS PATIENT UNDERWENT THAT DAY. TS RECOMMENDED TURNING RRT AND SAM BACK ON AT THE NEXT IN CLINIC VISIT. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SIGNAL ARTIFACT MONITOR (SAM) EVENT OCCURRED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RESULTING IN THE RESPIRATORY RATE TREND (RRT) SENSOR BEING DISABLED. TECHNICAL SERVICES (TS) DISCUSSED THE RRT DISABLED DUE TO NOISE WHICH WAS OVERSENSED, DUE TO ELECTROCAUTERY DURING A MEDICAL PROCEDURE THIS PATIENT UNDERWENT THAT DAY. TS RECOMMENDED TURNING RRT AND SAM BACK ON AT THE NEXT IN CLINIC VISIT. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391984 DYNAGEN CRT-D CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NIK BOSTON SCIENTIFIC CORPORATION G151 147820

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male