BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 3012442 · Received March 15, 2013

    Report

    Report Number
    9610579-2013-00025
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    May 7, 2008
    Report Date
    March 1, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THIS ICD AND ASSOCIATED LEADS WERE EXPLANTED DUE TO AN EROSION/INFECTION. THIS COMPLAINT IS ASSOCIATED TO THE LEAD CASE (B)(4) WITH THE FOLLOWING SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110455 OVATIO MRM SORIN CRM OVATIO DR 6550 S071025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention