BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1992025 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00975
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. THE 6949 SPRINT FIDELIS LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE REPORTED RETAINING A LAWYER, THAT THE PATIENT'S LEAD WAS CAUSING "PROBLEMS", AND THAT THE DEVICE WAS BEEPING. IT WAS ALSO REPORTED THAT THE LEAD WAS REPROGRAMMED BEFORE BEING REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R (B)(4) STENT GRAFT| (B)(4) IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) STENT GRAFT| (B)(4) STENT GRAFT| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) STENT GRAFT