BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 705852 · Received April 28, 2006

    Report

    Report Number
    6000030-2006-00687
    Event Type
    Injury
    Date Received
    April 28, 2006
    Date of Event
    November 23, 2005
    Report Date
    April 26, 2006
    Manufacturer
    RICE CREK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT OVER THE COURSE OF 3-4 MONTHS, THE PT WAS EXPERIENCING INCREASING RIGHT LOWER EXTREMITY PAIN AND NUMBNESS IN THE RIGHT FOOT. AN MRI SHOWED A GRANULOMA AT THE TIP OF THE CATHETER AND CATHETER FRACTURE. THE DEVICE SYSTEM WAS REVISED WITH THE PUMP BEING REPLACED AFTER AN IMPLANT DURATION OF 50 MONTHS DUE TO BATTERY DEPLETION. THE PT OUTCOME WAS REPORTED AS PAIN WELL RELIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATH LKK RICE CREK MFG 8709 J0058131R

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization