BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 SR

    MDR report key: 1922762 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00839
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 CAME INTO THE CLINIC COMPLAINING OF SHORTNESS OF BREATH DURING THE LAST WEEK. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF COPD. THE DEVICE WAS REPROGRAMMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KSR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 5024M IMPLANTABLE PACING LEAD