BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 5723038 · Received June 14, 2016

    Report

    Report Number
    1000165971-2016-00351
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 20, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ICD WAS INTERROGATED ON (B)(6) 2014, (B)(6) 2015. MEDICAL RECORDS DO NOT REVEAL ANY ANOMALY. ON (B)(6) 2016, AN ALERT WAS DISPLAYED (238 REINIZIALIZATION OF THE DEVICE / EXCESSIVE DEFIBRILLATION CHARGE TIME / SCV CONTINUITY > 3000 OHM SINCE (B)(6) 2014). THE BATTERY CURVE HAD A VERY STRANGE TREND AND ALL THE BATTERY PARAMETERS WERE INCONSISTENT (BATTERY VOLTAGE 120,1 V / MAGNET RATE 7680 MIN-1 / LAST CHARGE TIME 54,5 SEC / LAST 42J CHARGE DATED 2 (B)(6) 1982 / FINAL ENERGY 17,2 J / LAST SHOCK IMPEDANCE 1 OHM). LEAD PARAMETERS WERE IN THE NORMAL RANGE. THE PHYSICIAN DECIDED TO REPLACE THE ICD ON MONDAY (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378804 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2839

    Patients

    Seq Age Sex Outcome Treatment
    1