BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1800150 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00858
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INTERROGATED ON (B)(6) 2010. UPON INTERROGATION, IMPLANT SOFTWARE UPDATE PROCEDURE WAS SUSPENDED. RESET OF THE HOLTER MEMORIES WAS RECOMMENDED BY THE SORIN ENGINEER, SOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM CRT 8750 2384

    Patients

    Seq Age Sex Outcome Treatment
    1