BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2833435 · Received October 26, 2012

    Report

    Report Number
    9610579-2012-00103
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 9, 2012
    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). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE SUBJECT DEMO DEVICE WAS INTERROGATED IN ITS BOX BY THE SUBSIDIARY ON (B)(4) 2012. REPORTEDLY, A KNOWN PROGRAMMER SOFTWARE ISSUE (THERAPIES CAN BE PROGRAMMED IN SLOWVT ZONE EVEN WHEN VT ZONE IS OFF) HAS BEEN CORRECTED FOR OTHER MODELS, BUT IS STILL OBSERVED WITH THIS OVATIO ICD UPON INTERROGATION WITH 2.36J SOFTWARE VERSION. THE CUSTOMER REQUESTS A CORRECTION ALSO FOR OVATIO DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1