BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2915538 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    UPON IMPLANTATION OF THIS ICD ON (B)(6) 2012, THE 3 TACHYCARDIA DETECTION ZONES WERE PROGRAMMED (USING SMARTVIEW 2.36J PROGRAMMER SOFTWARE). DURING THE OPERATION, SETTINGS WERE CHANGED TO "VF ZONE" ONLY IN PREPARATION FOR DFT. HOWEVER, DFT WAS NOT PERFORMED CONSIDERING THE PT'S CONDITION; THEREFORE VT AND SLOW VT ZONES WERE RE-PROGRAMMED ON AGAIN. THE PHYSICIAN REPORTED UNEXPECTED CHANGE OF THE DETECTION RATE FOR SLOW VT (100 MIN-1 INSTEAD OF 130 MIN-1 AS PROGRAMMED ORIGINALLY). THE SUBSIDIARY WAS ABLE TO CONFIRM THE REPORTED BEHAVIOR USING 2 DEMO DEVICES (PARADYM VR 8250 AND PARADYM 2 CRT 8752): UNEXPECTED VALUES ARE DISPLAYED IN SOME PARAMETERS, REGARDLESS OF ORIGINAL SETTINGS, WHEN THE TACHYCARDIA ZONES ARE PROGRAMMED OFF AND THEN ON. THESE UNK VALUES ARE NOT THE "AS SHIPPED" SETTINGS. AN EXPLANATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13422 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM DR 8550 2632

    Patients

    Seq Age Sex Outcome Treatment
    1