BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2121787 · Received May 20, 2011

    Report

    Report Number
    1000165971-2011-00189
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 29, 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

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: THE PROGRAMMER FILES WERE REVIEWED. OVERSENSING DUE TO THE PHD FEATURE WAS IDENTIFIED FOR THIS REPORTED EVENT; IT SHOULD BE NOTED THAT THIS PHD FEATURE IS NOT AVAILABLE ON DEVICES APPROVED IN THE U.S., I.E NO SUCH OVERSENSING EVENT CAN OCCUR ON U.S MARKETED UNITS. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED THAT: - THE BATTERY VOLTAGE DROPPED DOWN TO 2.9V - THE MAGNET RATE WAS 87 MIN-1 - 767 VENTRICULAR FIBRILLATIONS EPISODES WERE RECORDED IN THE DEVICE MEMORY. THE PHYSICIAN REQUESTED AN EXPLANATION OF THE REPORTED BEHAVIOR RELATED TO THE BATTERY VOLTAGE DECREASE, OVERSENSING ASSOCIATED TO PHD FEATURE WAS IDENTIFIED FOR THE RECORDED EPISODES. IT SHOULD BE NOTED THAT THE PHD FEATURE IS NOT AVAILABLE IN US MARKETED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2452

    Patients

    Seq Age Sex Outcome Treatment
    1