BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3811749 · Received May 15, 2014

    Report

    Report Number
    1000165971-2014-00272
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING FOLLOW-UP ON (B)(6) 2014, NOISE WAS OBSERVED ON SONR SIGNAL USED FOR CRT OPTIMISATION.

    Description of Event or Problem · 1

    DURING FOLLOW-UP ON (B)(6) 2014, NOISE WAS OBSERVED ON SONR SIGNAL USED FOR CRT OPTIMISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290349 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2677

    Patients

    Seq Age Sex Outcome Treatment
    1