BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1000145 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00782
    Event Type
    Injury
    Date Received
    February 19, 2008
    Report Date
    January 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PHILLIPS ET AL. "IMAGING APPEARANCE OF INTRATHECAL CATHETER TIP GRANULOMAS: REPORT OF THREE CASES AND REVIEW OF THE LITERATURE." AM J ROENTGENOL 2007; 189(6): 1524. THREE PATIENTS WHO RECEIVED A SPINAL CATHETER FOR INTRATHECAL ADMINISTRATION OF OPIOIDS UNDERWENT SURGERY FOR REMOVAL OF AN INFLAMMATORY MASS AT THE INTRATHECAL CATHETER TIP. REPORTABLE EVENT: A WOMAN WITH FAILED BACK SYNDROME HAD PLACEMENT OF AN INTRATHECAL MORPHINE PUMP IN 2005 FOR PAIN CONTROL. A MYELOGRAM SHOWED ABNORMAL POOLING OF CONTRAST MATERIAL IMMEDIATELY PROXIMAL TO THE CATHETER TIP. IN 2006, THE PATIENT NOTICED DIFFICULTY IN CONTROLLING HER LEGS. SHE WAS ADMITTED TO THE HOSPITAL A MONTH LATER WITH A 0 OF 5 MOTOR STRENGTH SCORE IN THE LOWER EXTREMITIES, DECREASED RECTAL TONE, AND LACK OF BLADDER CONTROL. CONTRAST-ENHANCE MRI SHOWED A LESION VENTRAL TO THE SPINAL CORD. DURING INTRADURAL EXPLORATION, THE DISTAL ASPECT OF THE INTRATHECAL CATHETER WAS FOUND TO COURSE ALONG THE PERIPHERY OF THE LESION. THE CATHETER WAS IDENTIFIED AND DISSECTED OUT OF THE MASS. ALL BACTERIAL AND FUNGAL CULTURES WERE NEGATIVE. PT WAS DISCHARGED TO A REHAB FACILITY AND REMAINED PARAPLEGIC REQUIRING CHRONIC INDWELLING BLADDER CATHETERIZATION DUE TO LACK OF BLADDER CONTROL AND ASSISTANCE WITH BOWEL REGIMEN. SHE ALSO DEVELOPED STAGE 1-2 DECUBITUS ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LKK MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANTABLE INFUSION PUMP MODEL UNK| PROGRAMMER MODEL UNK