BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2201750 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03805
    Event Type
    Injury
    Date Received
    August 11, 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
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD FRACTURED AND THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, AND INCREASED THRESHOLDS. CAPTURE COULD NOT BE MAINTAINED, AND THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. IT WAS NOTED ON FLUOROSCOPY THAT THE LEAD PIN MIGHT BE PULLED BACK INTO THE CONNECTOR BLOCK. HOWEVER, AFTER RESEATING THE PIN THE HIGH IMPEDANCE, NO CAPTURE, AND STIMULATION CONTINUED. THE LEAD WAS CAPPED AND REPLACED, AND THE DEVICE REMAINS IN USE. 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 II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD