BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1051693 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02708
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS INCLUDED IN THE "UPDATED INFO - INFLAMMATORY MASS (GRANULOMA) AT OR NEAR THE DISTAL TIP OF INTRATHECAL CATHETERS" COMMUNICATION DATED JANUARY 2008.

    Description of Event or Problem · 1

    THE PT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND RIGHT SHOULDER AND BACK PAIN FOLLOWING A PUMP REFILL. SHE ALSO EXPERIENCED LEG NUMBNESS AND WAKING AT NIGHT WITH TREMORS. THE PT WAS AT HOME AND HER STATUS WAS 'FAIR'. THE PT'S HCP HAD BEEN NOTIFIED OF THE SYMPTOMS AND A CONSULTATION HAD BEEN SET UP. THE PUMP WAS USED TO DELIVER MORPHINE AND COMPOUNDED BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J12576R21

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8578 LOT# N117115| EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| PUMP MODEL # 863720| IMPLANTED:| IMPLANTED:| IMPLANTED: