BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAPPA 700 DR

    MDR report key: 1722943 · Received June 15, 2010

    Report

    Report Number
    2647346-2010-00317
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    December 29, 2004
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1510/1519-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE CONNECTOR BLOCK REMOVED. DEVICE NOT ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT HAD SHORTNESS OF BREATH AND WAS VERY TIRED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY 6 MONTHS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REPORTED THE PATIENT HAD LAST BEEN SEEN BY THEM (B) (6) 2004, AND THEY HAVE NO INFORMATION AS TO HOW THAT DEVICE CHECK WENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death