BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4281773 · Received November 26, 2014

    Report

    Report Number
    3007566237-2014-03439
    Event Type
    Injury
    Date Received
    November 26, 2014
    Report Date
    November 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    MEHTA, P., CHANTASI, K. ACUTE DISC HERNIATION RESULTING IN UNUSUAL BACLOFEN CATHETER IMPINGEMENT: A CASE REPORT. PM<(>&<)>R. 2014. 6 (9 SUPPL 1) S367. SUMMARY/REPORTED EVENTS: A (B)(6) YEAR-OLD FEMALE PATIENT WITH CEREBRAL PALSY WITH INTRATHECAL BACLOFEN PUMP PLACEMENT IN 2011 AND SCOLIOSIS S/P C2-S1 SPINAL FUSION PRESENTED TO THE EMERGENCY ROOM WITH WORSENING SPASTICITY. SHE REPORTS HAVING A PREVIOUS FALL AFTER HER LEG HAD ACUTELY GIVEN OUT AND SUBSEQUENTLY DEVELOPED SEVERE SPASTICITY OF HER LOWER EXTREMITIES. IN THE EMERGENCY ROOM, SHE WAS TREATED FOR DEHYDRATION WITH INTRAVENOUS FLUIDS AND EMPIRIC ANTIBIOTICS DESPITE A NEGATIVE INFECTIOUS WORK UP. SHE WAS ADMITTED TO THE REHABILITATION SERVICE FOR MANAGEMENT OF HER SPASTICITY. HER BACLOFEN PUMP WAS INTERROGATED AND REFILLED SHOWING NO EVIDENCE OF PUMP FAILURE AND DELIVERING APPROPRIATE DOSE. HER BASELINE DOSE WAS INCREASED A TOTAL OF 20% WITH MULTIPLE BOLUS TRIALS RESULTING IN NO EFFECT. SHE ACUTELY DEVELOPED LEFT LEG SENSORY LOSS AND WORSENING SPASTICITY. MAGNETIC RESONANCE IMAGING (MRI) SHOWED A NEW L2-L3 LEFT PARACENTRAL DISC EXTRUSION THAT DISPLACES THE THECAL SAC TO THE RIGHT AND POSTERIOR. NEUROSURGERY CALLED FOR EVALUATION OBTAINING UPRIGHT THORACIC AND LUMBAR SPINE X-RAYS SHOWING CATHETER IN PLACE AT APPROXIMATELY T11-T12 WITH NO DISCONNECTIONS OR INTERRUPTIONS NOTED THROUGHOUT THE CATHETER LENGTH. CONTRAST DYE STUDY SHOWED NO EVIDENCE OF LEAK OR BREAKS IN THE CATHETER SYSTEM; HOWEVER, COMPUTERIZED TOMOGRAM (CT) MYELOGRAM SHOWED A BLOCK SECONDARY TO AN ACUTE DISC HERNIATION AT L2- L3. HER BACLOFEN WAS TITRATED DOWN SIGNIFICANTLY TO AVOID A POTENTIAL BACLOFEN OVERDOSE. PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) FOR LUMBAR MICRODISCECTOMY OF THE LARGE DISC HERNIATION. HER SPASTICITY SIGNIFICANTLY IMPROVED AFTER THE PROCEDURE, AND SHE WAS SLOWLY TITRATED UP TO HER BASELINE BACLOFEN DOSE UNTIL DISCHARGE. SHE WAS ABLE TO AMBULATE WITH A WALKER AND PERFORM WHEELCHAIR TRANSFERS MORE EASILY. THIS WAS THE FIRST REPORTED CASE, TO THE AUTHORS' KNOWLEDGE, OF AN ACUTE DISC HERNIATION RESULTING IN THECAL COMPRESSION AND CATHETER IMPINGEMENT COMPLICATING BACLOFEN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767554 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R