BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2043248 · Received February 25, 2011

    Report

    Report Number
    1000165971-2011-00080
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 2, 2011
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEB 25TH, 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 IMPLANTED ON (B)(6) 2010, WITH A DEFIBRILLATION LEAD - GUIDANT 0185 - S/N (B)(4). THE PHYSICIAN REVIEWED FILES GENERATED DURING F/U PERFORMED ON (B)(6) 2010, AND OBSERVED NOISE OVERSENSING EPISODES RECORDED IN DEVICE MEMORY. THESE EPISODES WERE RECORDED WITHIN ONE WEEK AFTER IMPLANTATION, AND EXHIBIT 8HZ NOISE PATTERN THAT COULD BE RELATED TO THE MINUTE VENTILATION SENSOR (PHD ALGORITHM WAS ACTIVE - PROGRAMMED ON). 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 C.R.M., S.R.L. PARADYM CRT 8750 2404

    Patients

    Seq Age Sex Outcome Treatment
    1