BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 1051763 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02696
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A GRANULOMA. THE PATIENT'S PUMP AND CATHETER WERE EXPLANTED. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK MEDTRONIC NEUROMODULATION 8709 N081001020

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANTABLE INFUSION PUMP MODEL 863740| LOT #NGV400475H| PROGRAMMER MODEL 8840| EXPLANTED