BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2933542 · Received January 29, 2013

    Report

    Report Number
    3007566237-2013-00308
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THOMPSON, B. F., REEVES, R. K. SPASTICITY REFRACTORY TO HIGH DOSE INTRATHECAL BACLOFEN IN THE SETTING OF TRANSECTED SPINAL CORD WITH REACTIVE SUBARACHNOID OBSTRUCTION: A CASE REPORT. PM AND R. 2012;4(10):S354-S355. SUMMARY/REPORTED EVENT: A 23-YEAR-OLD MAN WITH TRAUMATIC T3 ASIA A PARAPLEGIA INVOLVING COMPLETE SPINAL CORD AND DURAL SAC TRANSECTION, STATUS POST-SURGICAL RECONSTRUCTION, PRESENTED WITH SEVERE LOWER EXTREMITY SPASTICITY REFRACTORY TO ESCALATING DOSES OF INTRATHECAL BACLOFEN (ITB) AND MULTIPLE BOLUS TRIALS THROUGH HIS PUMP. THE PATIENT HAD UNDERGONE ITB PUMP IMPLANTATION 10 YEARS PRIOR WITH SUBSEQUENT DEVICE REPLACEMENT AND MULTIPLE CATHETER REVISIONS FOR POOR RESPONSE. FLUOROSCOPIC DYE STUDIES CONSISTENTLY SHOWED ACCURATE DELIVERY OF BACLOFEN INTO THE INTRATHECAL SPACE. CT MYELOGRAM WAS ATTEMPTED AT THE L3 LEVEL; HOWEVER, NO CEREBRAL SPINAL FLUID (CSF) COULD BE WITHDRAWN. THE PATIENT WAS SENT FOR MRI OF THE SPINE. MRI REVEALED A LOCULATED CSF COLLECTION JUST DISTAL TO THE CATHETER TIP AT THE T7 LEVEL. EXTENSIVE SUBARACHNOID ADHESIONS AND EPIDURAL LIPOMATOSIS WERE IDENTIFIED DISTALLY WITH VIRTUALLY ABSENT CSF FLOW. IT WAS CONCLUDED THAT THE IMPAIRED CSF FLOW WAS PREVENTING ITB PENETRATION TO THE DISTAL CORD, LEADING TO ITS RELATIVE UNDEREXPOSURE. AN ATTEMPT TO STENT THE OBSTRUCTION WAS UNSUCCESSFUL. THE PATIENT'S DEVICE WAS ULTIMATELY REMOVED AND HIS SPASTICITY MANAGED WITH ORAL BACLOFEN. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38971 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention