BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2791206 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02282
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(4) 2012 15:00:09 AND (B)(4) 2012 09:00:12. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX VENTRICULAR PACE BI IMPEDANCE FROM 741 TO 4047 OHMS RANGE BETWEEN (B)(4) 2012. OVERSENSING WAS NOTED AS 14 VENTRICULAR NON SUSTAINED TACHYCARDIA EPISODES <=210 MS OCCURRED BETWEEN (B)(4) 2012 22:27:14 AND (B)(4) 2012 06:38:07. LEAD INTEGRITY ALERT WAS TRIGGERED AS TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(4) 2012 15:40:06 AND (B)(4) 2012 16:49:29. (B)(4). THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA (B)(4) - COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) - IMPEDANCE - HIGH RESISTANCE/IMPEDANCE (B)(4) 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 15:00:09 AND (B)(4) 2012 09:00:12. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX VENTRICULAR PACE BI IMPEDANCE = 741 TO 4047 OHMS RANGE BETWEEN (B)(4) 2012. (B)(4) SENSING - OVERSENSING (B)(4) 14 - VENTRICULAR NST<=210 MS BETWEEN (B)(4) 2012 22:27:14 AND (B)(4) 2012 06:38:07. (B)(4) STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED (B)(4) 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(4)2012 15:40:06 AND (B)(4) 2012 16:49:29.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED. DURING THE REVISION PROCEDURE, A LOOSE CONNECTION WAS OBSERVED AND CORRECTED. APPROXIMATELY THREE MONTHS LATER, ANOTHER LEAD INTEGRITY ALERT WAS TRIGGERED AND THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D294TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R 5594 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD