BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2201692 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03795
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    Z-0110-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) AND (B)(4): THE ACTUAL DEVICE AND LEAD WERE NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TWO - PORS (POWER ON RESET) ON (B)(6) 2011. ONE - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 10:02:20. DAILY PACE IMPEDANCE TREND DATA SHOW THE IMPEDANCE FOR VENTRICULAR PACE BI IMPEDANCE = 4047 OHMS AND ATRIAL PACE BI IMPEDANCE = 4047 OHMS BETWEEN (B)(6) 2011 AND (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED ON (B)(6) 2011. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY FOR BREAST CANCER AND THERE WAS AN ELECTRICAL RESET. THE RIGHT ATRIAL (RA) LEAD THE RIGHT VENTRICULAR (RV) LEAD AND BOTH LEFT VENTRICULAR (LV) LEADS SHOWED HIGH RESISTANCE/IMPEDANCE. IT WAS ALSO REPORTED THAT THE POWER-ON-RESET WAS CAUSED BY A POWER SUPPLY ISSUE WHICH MAY BE RELATED TO THE PATIENT'S SURGERY. THE FOLLOW-UP INFORMATION OBTAINED COULD NOT CONFIRM IF THERE WAS ANY INTERVENTION DONE. THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other