BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2151528 · Received June 24, 2011

    Report

    Report Number
    9610579-2011-00063
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 9, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING (B)(6) 2011 F/U, VENTRICULAR FIBRILLATION EPISODES RECORDED IN DEVICE MEMORY WERE SHOWING OVERSENSING AT VENTRICULAR SIDE. NEVERTHELESS, THE DEVICE DID NOT DELIVER ANY INAPPROPRIATE THERAPY. REPORTEDLY, THE VENTRICULAR SENSITIVITY WAS RE-PROGRAMMED FROM 0.6MV TO 0.8MV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 M071130

    Patients

    Seq Age Sex Outcome Treatment
    1