BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3864707 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11387
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    February 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
    MS, 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. PRODUCT ANALYSIS CANNOT BE PERFORMED AT THIS TIME DUE TO POSSIBLE PENDING LITIGATION. CONCOMITANT PRODUCT: 419388, LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE CONSIDER THIS REPORT REDACTED, AS FOLLOW-UP WITH THE PHYSICIAN'S OFFICE INDICATED THAT THE LONGEVITY WAS DUE TO THE PATIENT'S PHYSIOLOGY AND THAT THE DEVICE PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING "A LOT OF PROBLEMS" WITH THE DEVICE. IT WAS FURTHER REPORTED THAT THERE WAS HIGH THRESHOLD, AND THAT THE DEVICE WAS DRAINING MORE QUICKLY AS A RESULT. THE LEAD REMAINS IN USE, AND 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
    338349 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 00089 YR Hospitalization| R 694765 LEAD