BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2093306 · Received April 15, 2011

    Report

    Report Number
    1000165971-2011-00165
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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) 2011. LEAD CHECKS WERE PERFORMED AND NORMAL OPERATION WAS OBSERVED. INDUCTION TESTS WERE PERFORMED SUCCESSFULLY (14J SHOCK DELIVERED). HOWEVER, HIGH SHOCK IMPEDANCE (124 OHM) AND HIGH SHOCK PULSE DURATION (20MS) WERE OBSERVED. ADDITIONAL LEAD MEASUREMENTS SHOWED ABNORMAL VALUES (IMPEDANCE MEASUREMENTS >3000 OHM ON BOTH A AND V CHANNELS). NORMAL COIL CONTINUITY WAS OBSERVED. NEW IMPEDANCE MEASUREMENTS THEN SHOWED NORMAL VALUES AGAIN. RECOMMENDATIONS WERE PROVIDED BY SORIN: ALL LEAD CONNECTORS WERE CLEANED AND RECONNECTED TO THE ICD. NORMAL LEAD MEASUREMENTS WERE THEN OBSERVED. THE NEW INDUCTION PROCEDURE WAS SUCCESSFUL. ADDITIONAL IMPEDANCE MEASUREMENTS CONFIRMED NORMAL OPERATION OF THE SYSTEM. THEREFORE THE ICD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2503

    Patients

    Seq Age Sex Outcome Treatment
    1