BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1994395 · Received January 14, 2011

    Report

    Report Number
    1000165971-2011-00021
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 27, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS REPORT WAS IMPLANTED ON (B)(6) 2010. UPON SCHEDULED F/U ON (B)(6) 2010, ARRHYTHMIA EPISODES RECORDED IN THE IMPLANT MEMORIES WERE RETRIEVED AND REVIEWED. A 3 VT EPISODES LABELED AS "TREATED" WERE ADEQUATELY DIAGNOSED AND SUCCESSFULLY TREATED (ATP). A 1 VT EPISODE (WITH 1:1 RETROGRADE CONDUCTION) WAS ERRONEOUSLY CLASSIFIED AS A "SVT/ST" AND THEREFORE, NOT TREATED (HOWEVER, IT ENDED SPONTANEOUSLY AFTER ABOUT 2.5MIN). THE REPORTER COMPLAINED BECAUSE: THE ARRHYTHMIA DETECTION ALGORITHM (PARAD+) MISCLASSIFIED THIS VT EPISODE; THE ONSET OF THE MISCLASSIFIED VT EPISODE WAS ACTUALLY RECORDED IN THE "A RUN" EPISODE RECORDED JUST BEFORE; IT WAS IMPOSSIBLE TO TRACE BACK WHICH CYCLES CAUSED THIS MISCLASSIFICATION IN AVAILABLE EGMS AND MARKERS. RECOMMENDATIONS WERE REQUESTED FOR THIS PT (SUGGESTIONS FOR TACHY PARAMETERS REPROGRAMMING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM DR 8550 2423

    Patients

    Seq Age Sex Outcome Treatment
    1