BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 4110020 · Received September 23, 2014

    Report

    Report Number
    1000165971-2014-00541
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    SIMULTANEOUS INCREASE OF LV AND RV PACING IMPEDANCES (ABOVE 3000 OHMS) WAS OBSERVED ON APPROXIMATELY (B)(6) 2014. IN ADDITION, THE HEART RATE CURVE SHOWS A SUDDEN INCREASE TO 800MIN-1 AROUND (B)(6) 2014.

    Description of Event or Problem · 1

    SIMULTANEOUS INCREASE OF LV AND RV PACING IMPEDANCES (ABOVE 3000 OHMS) WAS OBSERVED ON APPROXIMATELY (B)(6) 2014. IN ADDITION, THE HEART RATE CURVE SHOWS A SUDDEN INCREASE TO 800MIN-1 AROUND (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589702 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) NIK SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2800

    Patients

    Seq Age Sex Outcome Treatment
    1