BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2211134 · Received August 8, 2011

    Report

    Report Number
    9610579-2011-00079
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 REPORT WAS IMPLANTED ON (B)(6) 2007. UPON A F/U ON (B)(6) 2011, IMPEDANCE AND CONTINUITY MEASUREMENTS WERE PERFORMED. SEVERAL ATTEMPTS OF THE SVC COIL CONTINUITY MEASUREMENT FAILED. REPORTEDLY, AFTER SEVERAL ATTEMPTS THE CONTINUITY MEASUREMENT WAS SUCCESSFUL AND THE RESULT WAS "NORMAL". THE REASON FOR THIS DIFFICULT MEASUREMENT WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO VR 6250 S070307

    Patients

    Seq Age Sex Outcome Treatment
    1