BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3991146 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14334
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 MEDICAL PRODUCTS: 407652, LEAD, IMPLANTED: (B)(6) 2008; 694765, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE DID NOT DETECT ANY PERFORMANCE ISSUES, BUT THE CALCULATED LONGEVITY RESULT OF 99.6% OF EXPECTED WAS LESS THAN THE PREDICTED VALUE BASED ON THE AVAILABLE PROGRAMMED PARAMETERS. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    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 REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) LESS THAN FOUR YEARS AFTER IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468398 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 00078 YR Hospitalization| R 419588, LEAD