BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1628933 · Received March 9, 2010

    Report

    Report Number
    1000165971-2010-00571
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 18, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORT WAS IMPLANTED ON (B) (6) 2008. UPON A SCHEDULED FOLLOW-UP ON (B) (6) 2010, SOME ISSUES WERE ENCOUNTERED WITH THE PROGRAMMING SYSTEM: THE USER WAS UNABLE TO PRINT WITH ORCHESTRA + PROGRAMMER (SOFTWARE (B) (4)); THE MESSAGE 'PRINTING IN PROGRESS' WAS DISPLAYED PERMANENTLY. THE PROGRAMMER CLOSED DOWN WHEN AN ATTEMPT TO INTERROGATE THE DEVICE WAS MADE. UPON INTERROGATION, A WARNING MESSAGE WAS DISPLAYED TO THE USER: PLEASE REFER TO USER HELP (27). DEVICE WAS REINITIALIZED 1 TIME SINCE BEGINNING OF LIFE. LAST RESET DATE 16.5.08 11:54. IN ADDITION, AN ARRHYTHMIA EPISODE (LABELED AS VENTRICULAR FIBRILLATION, DATED (B) (6) 2010 17:25) WAS STORED IN THE IMPLANT MEMORY AND WAS REPORTEDLY RELATED TO OVERSENSING ("DOUBLE SENSING"); THIS EPISODE WAS NOT TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM DR 8550 2270

    Patients

    Seq Age Sex Outcome Treatment
    1