BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 3905198 · Received July 1, 2014

    Report

    Report Number
    1000165971-2014-00387
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    December 16, 2013
    Report Date
    June 25, 2014
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A RESET OCCURRED ON THE SUBJECT ICD BETWEEN TWO FOLLOW-UPS. PROPER DEVICE OPERATION WAS CONFIRMED, BUT THE REPORTER REQUESTED AN EXPLANATION FOR THE RESET. PRELIMINARY ANALYSIS OF THE FILES RECEIVED REVEALED THAT FOLLOW-UPS HAVE BEEN PERFORMED ON (B)(6) 2013 AND ON (B)(6) 2014. LOGFILE DATED (B)(4) 2014 SUGGESTS THAT THE ICD RESET OCCURRED ON (B)(6) 2013 AT 10:39.

    Description of Event or Problem · 1

    REPORTEDLY, A RESET OCCURRED ON THE SUBJECT ICD BETWEEN TWO FOLLOW-UPS. PROPER DEVICE OPERATION WAS CONFIRMED, BUT THE REPORTER REQUESTED AN EXPLANATION FOR THE RESET. PRELIMINARY ANALYSIS OF THE FILES RECEIVED REVEALED THAT FOLLOW-UPS HAVE BEEN PERFORMED ON (B)(6) 2013 AND ON (B)(6) 2014. LOGFILE DATED (B)(6) 2014 SUGGESTS THAT THE ICD RESET OCCURRED ON (B)(6) 2013 AT 10:39.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383601 OVATIO DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM OVATIO VR 6250 S090818

    Patients

    Seq Age Sex Outcome Treatment
    1