BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3990068 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14496
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED AN ALERT FOR EXCESSIVE CHARGE TIME EOS (END OF SERVICE), THAT THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET, THAT THERE WAS A CHARGE CIRCUIT TIMEOUT ALERT, THAT THE HIGH VOLTAGE CAPACITOR CHARGE TIME WAS LONGER THAN EXPECTED FOR A DEVICE NOT YET AT ERI (ELECTIVE REPLACEMENT INDICATOR), AND THAT THE BATTERY INDICATOR SIGNIFIED THAT IT IS TIME FOR DEVICE REPLACEMENT.

    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: 419678, LEAD, IMPLANTED: (B)(6) 2011; 559453, LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY DEPARTMENT HAVING RECEIVED 83 APPROPRIATE SHOCKS DUE TO SUSTAINED VT (VENTRICULAR TACHYCARDIA). THE DEVICE WAS NOTED TO BE AT EOS (END OF SERVICE) AND THE CHARGE CIRCUIT WAS DISABLED. THERAPIES WERE TURNED OFF PENDING DEVICE REPLACEMENT AT A FUTURE DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462668 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 00069 YR Hospitalization| R 694765 LEAD