BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2810943 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06059
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BY THE PATIENT'S SPOUSE THAT THEY HEARD A "NOISE" COMING FROM THE PATIENT'S CHEST. THE PATIENT'S PHYSICIAN DIRECTED THEM TO THE EMERGENCY ROOM (ER). THE PATIENT'S SPOUSE CONFIRMS THAT THEIR DEVICE WAS CHECKED. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER IT WAS NOT AVAILABLE. 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 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 4196 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD