BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17523105 · Received August 12, 2023

    Report

    Report Number
    MW5130053
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COMPLAINT NOTES: Q: LIA TRIGGERED. THE OVERSENSING MARKERS. ARE NOT SHOWING NOISE ON THE EGMS, THOUGH THE RVC TO CAN HAS SOME BASELINE NOISE. COULD BE EML RECOMMENDED SEVERAL REAL TIME IMPEDANCES DURING ISOMETRICS AND POCKET MA NIP WHILE KOKING FOR IMPEDANCE VARIANCE AND ALSO ANY NOISE. IF NO IMPEDANCE VARIANCE AND NO NOISE, CONTINUE TO MONITOR. IF YOU CAN PRODUCE NOISE/OVERSENSING, OR SEE VARIANCE IN IMPEDANCES, MOST LIKELY PENDING LEAD ISSUE AND WOULD REQUIRE LEAD REPLACEMENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182327 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC 125

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown