BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1000052 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00685
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 6, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD INCREASED SPASTICITY AND FLUID COLLECTION OVER THE CATHETER SITE. A DYE STUDY WAS DONE (DATE NOT REPORTED) AND THE CATHETER WAS FOUND TO BE FRACTURED. THE PT WAS SCHEDULED FOR A CATHETER REVISION. THE PUMP WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8709 N089939021

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT # UNK| IMPLANTED| EXPLANTED| PUMP MODEL 863720