BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLINE

    MDR report key: 1781225 · Received August 3, 2010

    Report

    Report Number
    2182863-2010-00071
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4). DAMAGE WAS SUSTAINED TO THE HELIX, THE ANALYSIS COULD NOT DETERMINE WHEN THIS DAMAGE INCURRED, BUT IT DOESN NOT CONFORM TO ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HELIX ON THIS LEAD WOULD NOT DEPLOY PROPERLY DURING THE IMPLANTATION PROCEDURE. THEREFORE, IT WAS NOT IMPLANTED. NOTE: THIS EVENT OCCURRED SOMETIME IN (B)(6) 2010 AND WAS NOT REPORTED UNTIL JULY 1, 2010.

    Description of Event or Problem · 1

    THE HELIX ON THIS LEAD WOULD NOT DEPLOY PROPERLY DURING THE IMPLANTATION PROCEDURE. THEREFORE, IT WAS NOT IMPLANTED.NOTE: THIS EVENT OCCURRED SOMETIME IN (B) (6) 2010 AND WAS NOT REPORTED UNTIL JULY 1, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE LEAD MRM SORIN BIOMEDICA CRM S.R.L. 2CR-5

    Patients

    Seq Age Sex Outcome Treatment
    1