BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1021175 · Received March 28, 2008

    Report

    Report Number
    6000030-2008-01686
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 27, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PT'S LAST REFILL IN 2007, THE DOSE CONCENTRATION WAS INCREASED, SO THE PT WOULD ONLY REQUIRE A REFILL EVERY SIX MOS. THE PT REPORTED THAT SHE AWOKE IN THE MIDDLE OF THE NIGHT AND HER LEGS GAVE OUT AND SHE FELT ITCHING/TINGLING IN HER STOMACH. ADD'L INFO RECEIVED FROM THE HCP REPORTED THAT THE PT EXPERIENCED WEAKNESS. THE REASON WAS ULTIMATELY UNK, BUT WAS STRONGLY SUSPECTED TO BE A URINARY TRACT INFECTION (UTI). THE PT'S UTI WAS TREATED BY THE PT'S PRIMARY CARE PHYSICIAN AND THE PT DID NOT REQUIRE ADD'L EVAL BY THE SPASTICITY CLINIC. THE PT OUTCOME WAS REPORTED AS NO INJURY. THE PT'S PUMP CONTAINED BACLOFEN AT 167 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MFG 8711 J11474R38

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 862718| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| EXPLANTED