BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 3202694 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01003
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 27, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HCP REPORTED CATHETER REPLACEMENT DUE TO AN EPIDURAL CATHETER. NO PATIENT SYMPTOMS WERE REPORTED. NO PATIENT OUTCOME REPORTED. SYSTEM USED TO DELIVER BACLOFEN(UNKNOWN). A REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301718 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8709SC N175986009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention