BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1925194 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06236
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    May 11, 2010
    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
    TN, 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 PATIENT THINKS SHE HEARS THE PATIENT ALERT TONE (WHICIH PATIENT DESCRIBES AS A "BUZZING SOUND") FROM THE DEVICE, BUT CARELINK DOES NOT INDICATE ANY ALARM. IT WAS ALSO REPORTED THAT A LOOSE SET SCREW HAD EARLIER CAUSED A PATIENT ALERT DUE TO IMPEDANCE BEING OUT OF RANGE, AND THAT THE LOOSE SET SCREW WAS CORRECTED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 50 YR Other| R 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD