BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1931314 · Received November 10, 2010

    Report

    Report Number
    1000165971-2010-00973
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    March 23, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2010. 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 MDR WAS INTERROGATED DURING SCHEDULED F/U ON (B)(6) 2010. THE CALLER REPORTED THAT INCONSISTENT SHOCK STATISTICS WERE DISPLAYED BY THE PROGRAMMER THAT DAY: OVERVIEW SCREEN STATISTICS PART INDICATED 68 SHOCKS, ALTHOUGH THESE SHOCKS WERE NEVER DELIVERED NOR RECORDED IN THE ARRHYTHMIA AND THERAPY HISTORY. THESE INCONSISTENCIES WERE NOT OBSERVED UPON NEXT F/U VISIT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM CRT 8750 2382

    Patients

    Seq Age Sex Outcome Treatment
    1