BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2200551 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-00991
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. EVALUATION SUMMARY: (B)(4): UPON ANALYSIS, NORMAL DEPLETION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD HAD HIGH LEFT VENTRICLE THRESHOLD OF 6 VOLTS AT 0.7 MILLISECONDS. LEAD WILL BE MONITORED. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEAD WAS CAPPED/ABANDONED AND REPLACED. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-R) DEVICE REACHED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI.) THEREFORE THE CRT-D DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD