BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM CRT-D

    MDR report key: 2003984 · Received March 1, 2011

    Report

    Report Number
    2182863-2011-00017
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 4, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS DEVICE WAS INTERROGATED PRIOR TO AN IMPLANT AND WAS UNABLE TO INTERROGATE WITH MULTIPLE ERROR MESSAGES. THE CABLES WERE CHECKED, REPOSITIONED HEADER, PROGRAMMER REBOOTED, ROOMS CHANGED AND STILL THE SAME RESULTS. THE DEVICE WAS NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. IT WAS ALSO FOUND THAT THERE WERE 3 MICROPROCESSOR RESETS THAT WERE RECORDED.

    Description of Event or Problem · 1

    THIS DEVICE WAS INTERROGATED PRIOR TO AN IMPLANT AND WAS UNABLE TO INTERROGATE WITH MULTIPLE ERROR MESSAGES. THE CABLES WERE CHECKED, REPOSITIONED HEADER, PROGRAMMER REBOOTED, ROOMS CHANGED AND STILL THE SAME RESULTS. THE DEVICE WAS NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. IT WAS ALSO FOUND THAT THERE WERE 3 MICROPROCESSOR RESETS THAT WERE RECORDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1