BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER

    MDR report key: 66937 · Received January 31, 1997

    Report

    Report Number
    2182207-1997-00013
    Event Type
    Other
    Date Received
    January 31, 1997
    Date of Event
    May 1, 1996
    Report Date
    January 2, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    03/04/1998: G1-MANUFACTURING SITE NUMBER INFORMATION HAS BEEN CORRECTED.

    Description of Event or Problem · 1

    DISTAL PORTION OF CATHETER BROKE AND LODGED IN PT'S LOWER SPINAL CANAL AREA. DEVICE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER Implant INTRASPINAL CATHETER LKK MEDTRONIC, INC. 8703 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization 16R, IMPLANTED| MODEL 8615S IMPLANTABLE INFUSION PUMP, LOT #NBM000