BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2810552 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05770
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    April 5, 2012
    Report Date
    October 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS REVEALED A POWER ON RESET (POR) WAS INITIATED. THE POR OCCURRED ON (B)(6) 2012, THREE DAYS POST MORTEM.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) ADDITIONAL ANALYSIS INFORMATION INDICATED THAT AFTER TESTING NO CAUSE WAS IDENTIFIED FOR THE POWER ON RESET (POR).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED POST MORTEM, WAS ANALYZED, AND TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION NOTED THE PATIENT DIED IN A MANNER UNRELATED TO THE DEVICE.

    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 MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Other 4196 IMPLANTABLE PACING LEAD| 0158 COMPETITOR IMPLANTABLE TACHY LEAD| 4086 COMPETITOR IMPLANTABLE PACING LEAD