BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER

    MDR report key: 84641 · Received April 15, 1997

    Report

    Report Number
    2182207-1997-00097
    Event Type
    Other
    Date Received
    April 15, 1997
    Report Date
    March 13, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LNY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    12/18/1997: G1-MANUFACTURING SITE INFORMATION CORRECTED AND PROVIDED.

    Description of Event or Problem · 1

    LITERATURE REPORT OF CATHETER TIP FIBROSIS THAT REQUIRED REPLALCEMENT OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER INTRASPINAL CATHETER LNY MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization