BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 2210691 · Received August 8, 2011

    Report

    Report Number
    9610579-2011-00080
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    May 12, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW UP, THE ICD DEVICE INVOLVED IN THIS NOTIFICATION COULD NOT BE INTERROGATED. REPORTEDLY, IT WAS CONNECTED TO A DEFECTIVE MEDTRONIC SPRINT FIDELIS LEAD (UNDER ADVISORY), WHICH COULD HAVE GENERATED OVERSENSING; THREE SHOCKS HAD BEEN DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO CRT 6750 M060411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention