BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 2230663 · Received August 12, 2011

    Report

    Report Number
    9610579-2011-00084
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    REPORTEDLY ON (B)(6) 2011, THE PHYSICIAN OBSERVED A WARNING MESSAGE (ALLEGEDLY RELATED TO AN EPS SHOCK DATED (B)(6) 2009, I.E. THE DAY OF THE IMPLANTATION) STATING THAT THE DELIVERED ENERGY OF LAST SHOCK WAS 0.0J. REPORTEDLY, NO VF INDUCTION WAS PERFORMED DURING IMPLANTATION AND THE PATIENT NEVER RECEIVED A SHOCK. AN EXPLANTATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 S090402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention