BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2013566 · Received March 10, 2011

    Report

    Report Number
    2182863-2011-00019
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 11, 2011
    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), 2011THE ANALYSIS ON THIS DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, IT WAS REPORTED THAT THE RV SETSCREW WAS NOT WORKING PROPERLY; THEY COULD NOT SCREW THE GUIDANT LEAD INTO THE HEADER. A NEW SORIN PARADIGM WAS THEN IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, IT WAS REPORTED THAT THE RV SETSCREW WAS NOT WORKING PROPERLY; THEY COULD NOT SCREW THE GUIDANT LEAD INTO THE HEADER. A NEW SORIN PARADYM WAS THEN IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN BIOMEDICA CRM S.R.L. 8550

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR