BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1012469 · Received March 12, 2008

    Report

    Report Number
    6000030-2008-01213
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 26, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FAMILY MEMBER THAT THE PT HAD A PUMP REPLACEMENT DUE TO CRYSTALLIZED BACLOFEN AND PAIN MEDICATION IN THE PUMP. THE HCP REPORTED, THEY HAD NOTED VOLUME DISCREPANCIES OF LESS THAN 25%. THE PT HAD ALSO EXPERIENCED INCREASED SPASTICITY. THE HCP DECIDED TO REPLACE THE PUMP DUE TO THE VOLUME DISCREPANCIES AND PT SYMPTOMS. NO ADD'L DEVICE TROUBLESHOOTING WAS PERFORMED. IN 2008 DURING THE PROCEDURE, THE HCP NOTED THAT THE CATHETER WAS FRACTURED, SO CATHETER WAS REPLACED AS WELL. AFTER REPLACEMENT, WHILE IN THE HOSP, IT WAS REPORTED BY THE PT'S FAMILY THAT HIS TEMPERATURE WAS 100F AND BLOOD PRESSURE WAS DECREASING. THE PT HAD BEEN RECEIVING COMPOUNDED BACLOFEN AND MORPHINE, BUT IN LATE 2007, THE MEDICATION WAS SWITCHED TO LIORESAL. SINCE REPLACEMENT, THE DOSE OF LIORESAL HAD BEEN DECREASED AND THE PT WAS SEEN WEEKLY BY THE HCP FOR DOSE TITRATION. PT RECOVERED WITHOUT SEQUELA. 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 MANUFACTURING 8731 N002802233

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R IMPLANTED| EXPLANTED| PUMP MODEL 863740| IMPLANTED| PROGRAMMER MODEL 8840 LOT#UNK| EXPLANTED