BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1934011 · Received December 21, 2010

    Report

    Report Number
    2182863-2010-00129
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4) 2011. SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE MANUFACTURING RECORDS WERE REVIEWED. THE RECORDS DID NOT REVEAL ANY ABNORMALITY, NO CONCLUSION CAN BE DRAWN. LEAD WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(6) 2010A RESPONSE FROM THE MANUFACTURER IS PENDING. LEAD WAS NOT RETURNED

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED FOR HIGH THRESHOLD READINGS. DURING THE PROCESS OF FREEING THE LEAD FROM THE POCKET, IT WAS DAMAGED. A NEW ISOLINE LEAD WAS IMPLANTED.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED FOR HIGH THRESHOLD READINGS. DURING THE PROCESS OF FREEING THE LEAD FROM THE POCKET, IT WAS DAMAGED. A NEW ISOLINE LEAD WAS 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 82 YR