BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 326630 · Received April 9, 2001

    Report

    Report Number
    6000030-2001-00113
    Event Type
    Injury
    Date Received
    April 9, 2001
    Date of Event
    August 22, 2000
    Report Date
    March 29, 2001
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN INDURA CATHETER IMPLANTED ALONG WITH A SYNCHROMED EL, IMPLANTABLE INFUSION PUMP, IN 2000 FOR TREATMENT OF LEFT GROIN INTRACTABLE NEUROPATHIC PAIN. ON THE EVENT DATE THE PT PRESENTED WITH PARESTHESIA BEHIND THE RIGHT KNEE AND DOWN THE LEG TO FOOT. THE PT HAD RADICULAR PAIN AT THE DERMATOMAL LEVEL OF L1-L3. TWO DAYS LATER THE PT HAD AN MRI. THE PT WAS DIAGNOSED WITH A GRANULOMA MASS AT T12. THERE WAS NO DISC PROTRUSION AND NO SPINAL STENOSIS ON THE MRI. LAB FINDINGS INCLUDED: SED RATE OF 26 TEN DAYS FOLLOWING MRI, SED RATE OF 23 TWO DAYS LATER AND SCATTERED LYMPHOCYTES, OCCASIONAL MONOCYTES AND A RARE NEUTROPHIL IN THE CEREBRO-SPINAL FLUID. ALMOST 2 WEEKS FOLLOWING INITIAL LAB FINDINGS THE CATHETER WAS PULLED FROM THE SPINAL CANAL AND CUT AT 4 CM ABOVE SECURING DEVICE. THE MASS WAS NOT SURGICALLY REMOVED. THE CSF WAS NEGATIVE FOR ALL BACTERIAL AG DETECTION, NEGATIVE FOR CRYPTOCOCCUS, POSITIVE FOR AEROBIC MYCOBACTERIUM MALMOENSE. LATER IN 2000 THE PT HAD A NEW INTRATHECAL CATHETER ANASTOMOSED TO THE EXISTING CATHETER. PT STATUS AT PRESENT: CHRONIC PAIN CONTINUES, WITH WEAKNESS IN THE RIGHT LEG. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15642 INDURA CATHETER LKK MEDTRONIC INC. 8709 L74224

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention UNTIL DATE UNK.| MODEL #8627L18, IMPLANTED IN 2000,| SYNCHROMED EL IMPLANTABLE INFUSION PUMP,