BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 992635 · Received February 6, 2008

    Report

    Report Number
    2182207-2008-00557
    Event Type
    Malfunction
    Date Received
    February 6, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 1, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS RELATED TO MEDTRONIC NEUROMODULATION OFFICE OF MEDICAL AFFAIRS EVENTS AND HAS BEEN DISCUSSED WITH THE REPORTING SYSTEMS MONITORING BRACH OF FDA.

    Description of Event or Problem · 1

    THE HCP REPORTED CATHETER TROUBLESHOOTING FOR A PT RECEIVING ITB THERAPY. A CATHETER REVISION WAS BEING CONSIDERED. NO OTHER INFORMATION WAS PROVIDED WITH THE INITIAL REPORT. MULTIPLE ATTEMPTS TO FOLLOW-UP WITH REPORTER FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# UNKNOWN| EXPLANTED| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL PUMP