BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1022768 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01690
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    October 1, 2006
    Report Date
    February 27, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RETURN OF PAIN AND SPASTICITY DUE TO KINK/OCCLUSION AND "COILING OF THE CATHETER OUTSIDE OF THE EPIDURAL SPACE AT THE LUMBAR SITE WHICH WAS NOTED DURING A CONTRAST STUDY. DURING SURGERY FOR REVISION OF THE CATHETER, IT WAS NOTED THAT THE PUMP POCKET APPEARED TO BE INFECTED. CULTURES WERE TAKEN AND THE ENTIRE SYSTEM WAS REMOVED. THE CULTURES WERE NEGATIVE. THE PUMP CONTAINED COMPOUNDED BACLOFEN. THE PATIENT RECOVERED WITHOUT SEQUELA. PLEASE REFER TO MANUFACTURER'S REPORT#: 3004209178200801689.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 N086296029

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT#: UNK| PUMP MODEL #: 863740AA