BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3901473 · Received June 30, 2014

    Report

    Report Number
    1000165971-2014-00384
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON A FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PHYSICIAN OBSERVED WARNING MESSAGES RELATED TO HIGH RV LEAD IMPEDANCE. HE REQUIRES ANALYSIS AND RECOMMENDATIONS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED HIGH RV LEAD IMPEDANCE. THE IMPEDANCE AND CONTINUITY CURVES CLEARLY SHOW A GRADUAL INCREASE OF THE RV LEAD IMPEDANCE SINCE (B)(6) 2013 (SHORTLY AFTER IMPLANT). THE IMPEDANCE MEASUREMENTS NOW REACH VALUES ABOVE 3000 OHM. THE NON-SORIN RV DEFIBRILLATION LEAD WAS DESIGNED TO FEATURE HIGH IMPEDANCE, AS SHOWN IN THE ENDOTAK USER MANUAL. HOWEVER, SUCH IMPEDANCE INCREASE (OVER 3000OHM) IS UNUSUAL AND REMAINS UNEXPLAINED AT THIS POINT. NO OVERSENSING HAS BEEN OBSERVED. ANALYSIS OF AVAILABLE INFORMATION DID NOT REVEAL ANY INDICATION OF A LEAD OR CONNECTION ISSUE. SENSING AND PACING ARE NOT IMPACTED.

    Description of Event or Problem · 1

    UPON A FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PHYSICIAN OBSERVED WARNING MESSAGES RELATED TO HIGH RV LEAD IMPEDANCE. HE REQUIRES ANALYSIS AND RECOMMENDATIONS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED HIGH RV LEAD IMPEDANCE. THE IMPEDANCE AND CONTINUITY CURVES CLEARLY SHOW A GRADUAL INCREASE OF THE RV LEAD IMPEDANCE SINCE (B)(6) 2013 (SHORTLY AFTER IMPLANT). THE IMPEDANCE MEASUREMENTS NOW REACH VALUES ABOVE 3000 OHM. THE NON-SORIN RV DEFIBRILLATION LEAD WAS DESIGNED TO FEATURE HIGH IMPEDANCE, AS SHOWN IN THE ENDOTAK USER MANUAL. HOWEVER, SUCH IMPEDANCE INCREASE (OVER 3000OHM) IS UNUSUAL AND REMAINS UNEXPLAINED AT THIS POINT. NO OVERSENSING HAS BEEN OBSERVED. ANALYSIS OF AVAILABLE INFORMATION DID NOT REVEAL ANY INDICATION OF A LEAD OR CONNECTION ISSUE. SENSING AND PACING ARE NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380693 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF SONR CRT-D 9770 2594

    Patients

    Seq Age Sex Outcome Treatment
    1