BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 2203601 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01033
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT "I AM DIZZY AND I HAVE CHEST PAIN EVERY TIME I TAKE A DEEP BREATH." IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED FOR FATIGUE, HOWEVER DID NOT COMPLETE LAB TESTS AS REQUESTED. PATIENT HAS BEEN NON-COMPLIANT. FURTHERMORE PATIENT REQUESTED A NEW MEDICAL DOCTOR (MD) AND WAS PROVIDED A NEW MD TO SEE. 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 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other 4574 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD