BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2033806 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00077
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    SORIN CRM 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

    FEBRUARY 11, 2011. 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 IMPLANTED ON (B)(6) 2010 (BOX REPLACEMENT), AND CONNECTED TO THE ALREADY IMPLANTED DEFIBRILLATION LEAD - BS GUIDANT 0148 - S/N (B)(4) - IMPLANTED ON (B)(6)2005. DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2011, THE PHYSICIAN OBSERVED NOISE OVERSENSING: 8HZ NOISE PATTERN THAT COULD BE RELATED THE MINUTE VENTILATION SENSOR (PHD ALGORITHM WAS ACTIVE - PROGRAMMED ON). THIS FEATURE WAS SWITCHED OFF THAT DAY. IT SHOULD BE NOTED THAT NEITHER ATP NOR SHOCK THERAPY WAS DELIVERED DUE TO THIS OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2475

    Patients

    Seq Age Sex Outcome Treatment
    1