BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLINE

    MDR report key: 1900707 · Received November 16, 2010

    Report

    Report Number
    2182863-2010-00109
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 22, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4) 2011. THE DAMAGE TO THE DEFIBRILLATION COILS ARE ATTRIBUTED TO PASSAGE OF THE LEAD THROUGH A CONSTRICTED OPENING DURING THE IMPLANT ATTEMPT; PATIENT PHYSIOLOGY.

    Additional Manufacturer Narrative · 1

    NOVEMBER 16, 2010. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, THE COILS ON THIS LEAD SEPARATED. THEREFORE, IT WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, THE COILS ON THIS LEAD SEPARATED. THEREFORE, IT WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE LEAD MRM SORIN BIOMEDICA CRM S.R.L. 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR