BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2202068 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03861
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INTERMITTENT T WAVE OVERSENSING AFTER BI-VENTRICULAR PACING. IT IS UNCLEAR IF THE OVERSENSING IS OCCURRING ON THE RIGHT VENTRICULAR COMPETITOR LEAD OR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING IN THE CLINIC WAS CONDUCTED TO CHANGE THE DELAY BETWEEN THE LEFT VENTRICULAR AND THE RIGHT VENTRICULAR LEADS, AND THE OVERSENSING APPEARED TO BE ELIMINATED AND THE ICD 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 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention