BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1922943 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06014
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 1, 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
    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 DUE TO A FAILED LEFT VENTRICULAR (LV) LEAD IMPLANT ATTEMPT, THE LEFT VENTRICULAR PORT OF THE DEVICE WAS PLUGGED. THE PATIENT HEARD AN AUDIBLE ALERT TONE. FURTHER INVESTIGATION REVEALED THAT THE AUDIBLE TONE PORTION OF THE ALERT FOR THE LV LEAD HAD NOT BEEN PROGRAMMED "OFF." DEVICE STILL 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 71 YR Other 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD