BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1926305 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06405
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 RIGHT VENTRICULAR LEAD EXPERIENCED T-WAVE OVERSENSING. FURTHERMORE, THIS OVERSENSING LED TO A DECREASE IN THE DEVICE BI-VENTRICULAR PACING PERCENTAGE. BOTH THE LEAD AND THE DEVICE REMAIN 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD