BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 3991996 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14926
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    October 10, 2013
    Report Date
    February 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. 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 # PRODUCT ID# (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE 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: PRODUCT ID 5076-52, IMPLANTED: (B)(6) 2010; PRODUCT ID 694765, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION OBTAINED INDICATED THE DEVICE WAS EXPLANTED POST-MORTEM FOR CREMATION AND THE CAUSE OF DEATH WAS NOT RELATED TO THE OUT OF SPECIFICATION FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471470 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR 5071 LEAD