BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2955305 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01860
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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 : (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. CONCOMITANT PRODUCTS : 4244 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2004; 0158 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2004; LV/IS10 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED. NO INFORMATION WAS PROVIDED AND FOLLOW-UP IS IN PROGRESS TO DETERMINE WHY THE DEVICE WAS EXPLANTED. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59074 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 00067 YR Hospitalization| R 4512 COMPETITOR IMPLANTABLE PACING LEAD