BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2043268 · Received February 25, 2011

    Report

    Report Number
    9610579-2011-00016
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS REPORT WAS INTERROGATED ON (B)(6) 2011 AROUND 12:30 (INITIAL INTERROGATION, POST IMPLANT). THE PHYSICIAN REPORTED THAT THE PROGRAMMING SYSTEM SHOWED SEVERAL WARNING MESSAGES RELATED TO A RESET OF THE ICD (LAST RESET DATE: (B)(6) 2011 12:32; [27] THE DEVICE WAS RE-INITIALIZED 1 TIME SINCE THE BEGINNING OF LIFE; [33] NUMBER OF RE-INITIALIZATIONS BY THE PROGRAMMER: HE/SHE REQUESTED AN EXPLANATION ABOUT THESE WARNINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 S100219

    Patients

    Seq Age Sex Outcome Treatment
    1