BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 2190713 · Received July 26, 2011

    Report

    Report Number
    1000165971-2011-00266
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    November 19, 2010
    Report Date
    July 20, 2011
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANT ATTEMPT OF THE SUBJECT LEAD, THE STYLET PERFORATED THE LEAD BODY, WHICH WAS VISIBLE BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN CRM ISOLINE 2CR6 2478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention