BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2182963 · Received July 28, 2011

    Report

    Report Number
    2182863-2011-00065
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011.A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4). SINCE THE DEVICE REMAINS IMPLANTED, THE FILES FROM THE PROGRAMMER WERE REVIEWED. AS REPORTED, AND AS CONFIRMED UPON FILE REVIEW, THIS PATIENT HAD ATRIAL ARRHYTHMIAS WHICH WERE CONDUCTED TO THE VENTRICLES AND SHOULD HAVE BEEN ADEQUATELY CLASSIFIED AS SVT/ST EPISODES. UNFORTUNATELY, INTERMITTENT ATRIAL UNDERSENSING OCCURRED, AS OBSERVED ON THE EGMS AND MARKERS, AND THE PR ASSOCIATION CRITERION WAS THEREFORE INADEQUATELY ASSESSED BY THE ALGORITHM. SOME EPISODES WERE THEREFORE MISCLASSIFIED, AND INAPPROPRIATE THERAPIES WERE DELIVERED. THE LOSS OF ATRIAL SENSING OBSERVED COULD HAVE RESULTED FROM THE PROGRAMMED ATRIAL SENSITIVITY VALUE TOO LOW AND/OR THE ATRIAL EVENTS OCCURING INSIDE THE ATRIAL REFRACTORY PERIOD POST VENTRICULAR SENSING, POSSIBLY DUE TO THE REPORTED LONG PR INTERVALS. RECOMMENDATIONS WERE INCLUDED IN THE ANALYSIS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    TWO DAYS AFTER IMPLANTATION, AN INTERROGATION WAS PERFORMED AND DIAGNOSTIC REVIEWS SHOWED THE PATIENT HAD RECEIVED ATP AND 43 SHOCKS. THE SVT/ST-VT EPISODE SHOWED THAT THE PATIENT RECEIVED THERAPY DUE TO ATRIAL UNDERSENSING. THE DEVICE REMAINS IMPLANTED; THE FILES FROM THE PROGRAMMER WERE SENT TO THE MANUFACTURER FOR REVIEW.

    Description of Event or Problem · 1

    TWO DAYS AFTER IMPLANTATION, AN INTERROGATION WAS PERFORMED AND DIAGNOSTIC REVIEWS SHOWED THE PATIENT HAD RECEIVED ATP AND 43 SHOCKS. THE SVT/ST-VT EPISODE SHOWED THAT THE PATIENT RECEIVED THERAPY DUE TO ATRIAL UNDERSENSING. THE DEVICE REMAINS IMPLANTED; THE FILES FROM THE PROGRAMMER WERE SENT TO THE MANUFACTURER FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN BIOMEDICA CRM S.R.L. 8550

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR