BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3974822 · Received August 4, 2014

    Report

    Report Number
    1000165971-2014-00438
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 13, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIANS RECEIVED SUCCESSIVELY TWO REMOTE MONITORING REPORTS FOR THE SUBJECT ICD WHERE THE VENTRICULAR DEFIBRILLATION LEAD CONTINUITY VALUES WERE IDENTICAL (RV COIL = 380 OHMS, SVC COIL = 383 OHMS). THE PHYSICIANS WOULD LIKE TO KNOW WHY A YELLOW ALERT WAS DISPLAYED REGARDING THESE VALUES, ALTHOUGH THE VALUES ARE THE SAME? DURING PLANNED FOLLOW-UP INTERROGATIONS, NORMAL RESULTS ARE DISPLAYED FOR LEAD CONTINUITIES. THE PHYSICIANS WOULD LIKE AN EXPLANATION FOR THIS DISCREPANCY.

    Description of Event or Problem · 1

    THE PHYSICIANS RECEIVED SUCCESSIVELY TWO REMOTE MONITORING REPORTS FOR THE SUBJECT ICD WHERE THE VENTRICULAR DEFIBRILLATION LEAD CONTINUITY VALUES WERE IDENTICAL (RV COIL = 380 OHMS, SVC COIL = 383 OHMS). THE PHYSICIANS WOULD LIKE TO KNOW WHY A YELLOW ALERT WAS DISPLAYED REGARDING THESE VALUES, ALTHOUGH THE VALUES ARE THE SAME? DURING PLANNED FOLLOW-UP INTERROGATIONS, NORMAL RESULTS ARE DISPLAYED FOR LEAD CONTINUITIES. THE PHYSICIANS WOULD LIKE AN EXPLANATION FOR THIS DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453297 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2603

    Patients

    Seq Age Sex Outcome Treatment
    1