BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2063861 · Received March 23, 2011

    Report

    Report Number
    1000165971-2011-00118
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR WAS INTERROGATED UPON SCHEDULED FOLLOW-UP ON (B)(6) 2011. THE PHYSICIAN REPORTED THAT HE OBSERVED ONE RECORDED EPISODE OF VENTRICULAR NOISE OVERSENSING, CLASSIFIED AS VF. THIS NOISE PHENOMENON COULD NOT BE REPRODUCED, REPORTEDLY. ANALYSIS AND SUGGESTIONS WERE REQUESTED. PRELIMINARY ANALYSIS SUGGESTS A PHENOMENON RELATED TO 50HZ EXTERNAL EMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2493

    Patients

    Seq Age Sex Outcome Treatment
    1