BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 497182 · Received November 24, 2003

    Report

    Report Number
    2182207-2003-01022
    Event Type
    Injury
    Date Received
    November 24, 2003
    Report Date
    October 23, 2003
    Manufacturer
    NEURO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE REPORT OF A GRANULOMATOUS MASS AT THE CATHETER TIP REPORTED IN FERNANDEZ, JULIUS., ET AL. "CATHETER TIP GRANULOMA ASSOCIATED WITH SACRAL REGION INTRATHECAL DRUG ADMINISTRATION." NEUROMODULATION, VOLUME 6, NUMBER 4, 2003 225 - 228. THE PATIENT HAD BEEN RECEIVING HYDROMORPHONE 400 MCG/CC AT 110 MG/DAY FOR THREE YEARS TO TREAT PAIN DUE TO FAILED BACK SURGERY SYNDROME. THE PATIENT DEVELOPED PROGRESSIVE SADDLE ANESTHESIA AND INCREASING URINARY INCONTINENCE. ANAL SPHINCTER TONE WAS MARKEDLY DECREASED. A LUMBOSACRAL MRI SHOWED AN INTRADURAL LESION ASSOCIATED WITH THE CATHETER TIP FROM S1 TO S2. THE PATIENT UNDERWENT A LAMINECTOMY OF S1 AND S2. ARACHNOIDITIS WAS IDENTIFIED DURING OPENING OF THE DURA. A GRAY TAN FIBROUS MASS WITH A NECROTIC LIQUID CORE WAS REMOVED IN PIECES. THE MASS WAS DENSELY ADHERENT TO THE NERVE ROOTS. THE CATHETER WAS FOUND AT THE CENTER OF THE LESION. PATHOLOGY REVEALED A STERILE INFLAMMATORY MASS CONSISTENT WITH CATHETER TIP GRANULOMA. POSTOP, THE PATIENT HAS NOT MADE NEUROLOGIC IMPROVEMENT WITH CONTINUED SENSORY DISTURBANCES AND BOWEL/BLADDER DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED CATHETER LKK NEURO UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PUMP MODEL UNK, IMP: UNK, EXP: UNK.