BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLINE

    MDR report key: 1942394 · Received December 30, 2010

    Report

    Report Number
    2182863-2010-00133
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    DECEMBER 30, 2010/ THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, THE HELIX COULD NOT BE RETRACTED. THE LEAD WAS NOT USED, A NEW ISOLINE WAS SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, THE HELIX COULD NOT BE RETRACTED. THE LEAD WAS NOT USED, A NEW ISOLINE WAS SUCCESSFULLY 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 84 YR