BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 3894780 · Received June 25, 2014

    Report

    Report Number
    1000165971-2014-00368
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 A FOLLOW-UP WAS CONDUCTED FOR THE SUBJECT ICD. ACCORDING TO THE REPORTER, THE PROGRAMMER DISPLAYED A MESSAGE STATING THAT A DEVICE RESET HAD OCCURRED. VERIFICATION OF THE DEVICE INTEGRITY AND PATIENT MANAGEMENT RECOMMENDATIONS WERE REQUESTED. PRELIMINARY ANALYSIS OF THE PROGRAMMER FILES REVEALED THAT THE LAST RESET OCCURRED ON (B)(6) 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A FOLLOW-UP WAS CONDUCTED FOR THE SUBJECT ICD. ACCORDING TO THE REPORTER, THE PROGRAMMER DISPLAYED A MESSAGE STATING THAT A DEVICE RESET HAD OCCURRED. VERIFICATION OF THE DEVICE INTEGRITY AND PATIENT MANAGEMENT RECOMMENDATIONS WERE REQUESTED. PRELIMINARY ANALYSIS OF THE PROGRAMMER FILES REVEALED THAT THE LAST RESET OCCURRED ON (B)(6)2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370428 OVATIO DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM OVATIO DR 6550 M091023

    Patients

    Seq Age Sex Outcome Treatment
    1