BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1962152 · Received January 17, 2011

    Report

    Report Number
    2182863-2011-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    July 2, 2010
    Report Date
    December 20, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    JANUARY 17, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    THE RV SETSCREW WAS NOT WORKING PROPERLY DURING THE IMPLANTATION PROCEDURE. A NEW PARADIGM WAS IMPLANTED SUCCESSFULLY. NOTE: QA WAS NOT NOTIFIED OF THIS CASE UNTIL (B)(6) 2010.

    Description of Event or Problem · 1

    THE RV SETSCREW WAS NOT WORKING PROPERLY DURING THE IMPLANTATION PROCEDURE. A NEW PARADIGM WAS IMPLANTED SUCCESSFULLY. NOTE: QA WAS NOT NOTIFIED OF THIS CASE UNTIL DECEMBER 20, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN BIOMEDICA CRM S.R.L. 8750

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR