BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3861579 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11172
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRELIMINARY ANALYSIS CONFIRMED THE LONG CHARGE TIME AND THE LOW BATTERY VOLTAGE. FURTHER ANALYSIS FOUND THE DEVICE TO HAVE NOMINAL CHARGE TIMES AND VOLTAGES WHEN POWERED WITH AN EXTERNAL POWER SUPPLY. THESE RESULTS WERE CONSISTENT WITH THE REPORTED LONG CHARGE TIMES BEING ATTRIBUTED TO THE DEVICE BATTERY. FURTHER ANALYSIS OF THE BATTERY CELL FOUND NO INTERNAL SHORT IN THE BATTERY. HOWEVER, THE CONDITION OF THE ANODE SUGGESTS THE BATTERY SAW A HIGHER CURRENT DRAIN RATE, WHICH WOULD INCREASE THE DISCHARGE OF THE LITHIUM ALONG THE EDGES AND IN THE TURNS, AS SEEN IN THE BATTERY.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 419488, LEAD, IMPLANTED: (B)(6) 2005; 5076-52, LEAD, IMPLANTED: (B)(6) 2005; 5076-52, LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED EOS (END OF SERVICE) SUDDENLY WITHOUT TRIGGERING RRT (RECOMMEND REPLACEMENT TIME). EOS WAS DUE TO LONG CHARGE TIME. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343189 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 694958 LEAD