BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELIX II

    MDR report key: 1933958 · Received December 21, 2010

    Report

    Report Number
    2182863-2010-00128
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 23, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4), 2010. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AFTER A YEAR OF IMPLANTATION, THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. A NEW OSCOR LEAD WAS IMPLANTED.

    Description of Event or Problem · 1

    AFTER A YEAR OF IMPLANTATION, THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. A NEW OSCOR LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELIX II STEROID LEAD DTB SORIN BIOMEDICA CRM S.R.L. BRF25D

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR