BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2965096 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02139
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 23, 2012
    Report Date
    December 17, 2012
    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
    CA, 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. CONCOMITANT CONTINUED: 5076-58 IMPLANTABLE PACING LEAD (B)(6) 2009; 1058T COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 DEVICE HAD EARLY ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69339 CONCERTO CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 694765 IMPLANTABLE TACHY LEAD