BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1002557 · Received February 8, 2008

    Report

    Report Number
    6000030-2008-00592
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    October 23, 2007
    Report Date
    January 28, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH RETURN OF SYMPTOMS FOLLOWING PUMP REPLACEMENT. THE PT HAD BEEN RECEIVING ORAL BACLOFEN WHICH HAD IMPROVED THE PT'S SYMPTOMS. THE PT WAS SCHEDULED FOR ADDITIONAL DIAGNOSTICS AND PROGRAMMING. IN THE SAME MONTH IN 2008: ADDITIONAL INFO RECEIVED FROM THE HCP REPORTED THAT THE PT ALSO EXPERIENCED IRRITABILITY. THE PT'S SYMPTOMS WERE DUE TO UNDERDOSING. THE PT'S DOSE WAS INCREASED ON FLEX SCHEDULING WHICH APPEARED TO HAVE HELPED. ON 01/28/2008: ADDITIONAL INFO RECEIVED INDICATED THE PT CONTINUES TO HAVE AN OVERALL LOSS OF THERAPEUTIC EFFECT WITH MORE SPASMS ON THE RIGHT SIDE. ALL SYMPTOMS STARTED FOLLOWING THE REPLACEMENT OF THE PT'S PUMP IN OCTOBER. THE PT CONTINUES TO BE TREATED WITH ORAL BACLOFEN AS WELL AS INCREASING DOSES OF THE INTRATHECAL LIORESAL. ON SIX DAYS EARLIER, THE PT'S DOSE OF LIORESAL WAS INCREASED FROM 154.9 MCG/DAY TO 180 MCG/DAY BUT THE PT CONTINUED TO HAVE SPASTICITY. A ROTOR STUDY SHOWED NO ISSUES. THE HCP REPORTED HAVING DIFFICULTY ASPIRATING FLUID THROUGH THE CAP. ONLY 0.8CC OF FLUID WERE ABLE TO BE ASPIRATED. FURTHER TROUBLESHOOTING IS BEING CONSIDERED BY THE HCP INCLUDING AN INDIUM DYE STUDY AND TESTING OF THE DRUG IN THE PUMP. THE HCP IS QUESTIONING IF THE PUMP WAS FILLED WITH 500 MCG/ML LIORESAL INSTEAD OF 2000 MCG/ML WHEN IT WAS PLACED. THE HCP HAS NOT BEEN ABLE TO CONFIRM THROUGH POST OPERATIVE NOTES OR PHARMACY RECORDS WHICH CONCENTRATION WAS PLACED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709 J0058228R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED| PUMP MODEL 8637| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT#UNK