BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1790887 · Received August 5, 2010

    Report

    Report Number
    1000165971-2010-00855
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 29, 2010
    Manufacturer
    SORIN BIOMEDICA 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

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

    Description of Event or Problem · 1

    REPORTEDLY, DURING AN ICD IMPLANT, DAMAGE OF THE SVC COIL WAS IDENTIFIED. THE PHYSICIAN DECIDED TO REPLACE THIS LEAD WITH ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN BIOMEDICA CRM ISOLINE 2CT6 2453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention