BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1854905 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04373
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 WAS HAVING POCKET STIMULATION SINCE THE DEVICE REPLACEMENT. THE STIMULATION WAS REPRODUCED AT HIGH OUTPUT ON THE LV LEAD. THE DEVICE IS STILL IN USE. 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 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE TACHY LEAD