BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3992023 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14923
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    March 12, 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

    PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED. SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. THE RESULT OF ANALYSIS IS INCONCLUSIVE. CONCOMITANT MEDICAL PRODUCTS: 5554-53 LEAD, IMPLANTED (B)(6) 2011; 419688 LEAD, IMPLANTED (B)(6)2011. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470759 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 00081 YR Hospitalization| R 6944-65 LEAD