BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 973830 · Received January 3, 2008

    Report

    Report Number
    6000030-2008-00016
    Event Type
    Injury
    Date Received
    January 3, 2008
    Date of Event
    June 4, 2007
    Report Date
    December 4, 2007
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A RECENT CATHETER REVISION, THE PT'S FAMILY MEMBER VOICED CONCERN DUE TO THIS BEING THE SECOND CATHETER REPLACEMENT. FOLLOW UP WITH THE HCP REVEALED THE CATHETER HAD NO DEFECT, THE HCP WANTED IT PLACED HIGHER FOR MORE THERAPEUTIC EFFECT TO THE UPPER EXTREMITIES. SEE MFR REPORT #6000030-2007-04524.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8709 J11622R16

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention PROGRAMMER MODEL PROGRAMMER| IMPLANTED| LOT #NGH013498R| EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8627L18| EXPLANTED