BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3063409 · Received April 12, 2013

    Report

    Report Number
    1000165971-2013-00204
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SORIN 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)(4), 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    UPON INTERROGATION OF THE ICD ON (B)(6) 2013, THE IMPLANT MEMORIES (AIDA) HAD NOT BEEN RESET COMPLETELY. DURING THE FIRST INTERROGATION, STATISTICS WERE NOT AVAILABLE. DURING THE SECOND INTERROGATION, NO EGMS COULD BE REVIEWED WHEREAS THE ARRHYTHMIA AND THERAPY HISTORY SCREEN CONFIRMED THAT A VENTRICULAR ARRHYTHMIA EPISODE (VF) HAD BEEN TREATED 2 DAYS BEFORE. THE PHYSICIAN REQUESTED AN EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157801 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM DR 8550 2473

    Patients

    Seq Age Sex Outcome Treatment
    1