BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1884937 · Received October 18, 2010

    Report

    Report Number
    1000165971-2010-00949
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 15, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. 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 THE IMPLANT ATTEMPT, DIFFICULTIES WERE ENCOUNTERED WHILE OPERATING THE FIXATION MECHANISM OF THE DEVICE. ONCE POSITIONED, IT WAS POSSIBLE TO EXTEND THE HELIX. THE PHYSICIAN USED A SCREWDRIVER STYLET FROM A MEDTRONIC LEAD TO EXTEND THE HELIX, BUT THIS STYLET COULD NOT BE REMOVED. THE LEAD WAS REMOVED FROM THE PT, AND ANOTHER LEAD WAS SUBSEQUENTLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE MRM SORIN BIOMEDICA C.R.M. ISOLINE 2CR6 2447

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention