BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2065889 · Received April 8, 2011

    Report

    Report Number
    1000165971-2011-00160
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04/08/2011: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE, ACTIVE FIXATION FUNCTION WAS ABNORMAL. THE ABNORMALITY WAS OBSERVED DURING THE SECOND POSITION ATTEMPT. ANOTHER LEAD WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2486

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention