BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 1933020 · Received December 20, 2010

    Report

    Report Number
    2182863-2010-00126
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 22, 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. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE WAS CAPPED, NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED DURING AN ICD UPGRADE DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE LEAD WAS DISLODGED IN THE ATRIUM AND THERE WAS A LOT OF TISSUE IN THE COIL AND THEREFORE COULD NOT BE REFIXATED. A NEW LEAD WAS IMPLANTED.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED DURING AN ICD UPGRADE DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE LEAD WAS DISLODGED IN THE ATRIUM AND THERE WAS A LOT OF TISSUE IN THE COIL AND THEREFORE COULD NOT BE REFIXATED. A NEW 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 84 YR