BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1012967 · Received March 13, 2008

    Report

    Report Number
    6000030-2008-01228
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 12, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHE EXPERIENCES A BURNING SENSATION ALL OVER HER BACK AREA. THIS HAS BEEN OCCURRING SINCE 2001. THE REPORTER ALSO INDICATED THAT THIS SENSATION OCCURS APPROX 5 MONTHS BEFORE SHE IS DUE FOR A BACLOFEN REFILL AND THAT THE SENSATION GOES AWAY A COUPLE OF DAYS AFTER HER BACLOFEN REFILL. THE PT REPORTS THAT THE BURNING SENSATION IS OCCURRING AGAIN AND THAT SHE IS DUE FOR A REFILL IN 2008. IT WAS ALSO REPORTS THAT APPROX ONE MONTH AGO, WHILE SITTING ON THE TOILET, SHE "FELT ASLEEP OR PASSED OUT." THE PT WAS REDIRECTED TO HER HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8711 J0058136R

    Patients

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