BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 5347636 · Received January 6, 2016

    Report

    Report Number
    3007566237-2016-00057
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    August 20, 2013
    Report Date
    August 8, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    CHATZIKALFAS, A., KOULOUSAKIS, A.A.K. MALFUNCTION OF CRANIAL NERVES AS A RESULT OF DISLOCATED INTRATHECAL CATHETER (10617). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 255. SUMMARY: FOR MORE THAN 25 YEARS THE INTRATHECAL APPLICATION OF BACLOFEN HAS BEEN EFFECTIVELY USED IN THE TREATMENT OF SPASTICITY. ONE OF THE MOST COMMON COMPLICATIONS IS THE DISLOCATION OF THE INTRATHECAL CATHETER. IN MOST OF THE CASES A CAUDAL DISLOCATION IS BEEN OBSERVED. CRANIAL DISLOCATION OF THE INTRATHECAL CATHETER IS VERY RARE AND IN MOST CASES DOESN'T AFFECT THE INTRATHECAL BACLOFEN TREATMENT. REPORTED EVENTS: WE REPORT THE CASE OF A (B)(6) FEMALE PATIENT WITH A SPASTIC HEMIPARESIS ON THE RIGHT SIDE BECAUSE OF AN INFANTILE CEREBRAL PARESIS. THE NEUROLOGICAL STATUS SHOWED A MODERATE TO SEVERE SPASTIC HEMIPARESIS. THE PATIENT HAD TO USE A WHEELCHAIR BECAUSE OF THE SPASTICITY AND BECAUSE OF THE NEED FOR HELP IN EVERY ASPECT OF HER DAILY ACTIVITIES SHE HAD TO LIVE IN A SPECIAL SHELTER. RESULTS: IN (B)(6) 2013 WE IMPLANTED THE INTRATHECAL CATHETER AND THE MEDICAL PUMP FILLED WITH BACLOFEN (SYNCROMED II, 40ML, MEDTRONIC). THE X-RAY CONTROL REVEALED THAT THE PICK OF THE CATHETER WAS AT THE LEVEL OF TH 3. A COUPLE OF MONTHS AFTER THE OR AND AFTER FINE TUNING OF THE INTRATHECAL DOSIS OF BACLOFEN, THE PATIENT WAS ABLE TO RIDE A BICYCLE, COULD ATTEND ALMOST 100% TO HER OWN NEEDS AND HAD MOVED TO HER OWN APARTMENT. ON (B)(6) 2013 THE PATIENT WAS RUSHED IN TO A REGIONAL HOSPITAL BECAUSE OF HEADACHES, DOUBLE VISION AND PAIN AT THE BACK OF HER NECK. THE NEUROLOGICAL EVALUATION REVEALED A N. ABDUZENS AND N. OCCULOMOTORIUS PARESIS ON THE LEFT SIDE. THE CCT SCAN SHOWED A CRANIAL DISLOCATION OF THE INTRATHECAL CATHETER THROUGH THE FORAMEN MAGNUM IN THE BASIS OF THE SKULL AND DIRECT CONTACT TO THE ABOVE MENTIONED CRANIAL NERVES. MOREOVER WE WERE SURPRISED TO SEE THAT THE EFFICIENCY OF THE ITB THERAPY HASN'T CHANGED. ON THE (B)(6) WE CORRECTED THE INTRATHECAL CATHETER. DURING THE OR WE HAD TO PULL THE CATHETER 22CM BACK BEFORE IT TOOK ITS PREVIOUS POSITION. DIRECTLY AFTER THE OR ALL NEUROLOGICAL SYMPTOMS WENT BACK TO NORMAL INCLUDING THE PAIN IN THE BACK OF THE NECK, THE HEADACHES AND THE DOUBLE VISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE POST-OP NEUROLOGICAL STATUS INCLUDED HEMIPARESIS AND HEMISPASTICITY SUBSIDED UP TO 70%. IN (B)(6) 2013 THE PATIENT HAD TO BE ADMITTED TO THE CLINIC BECAUSE OF A LOSS OF EFFECTIVITY OF THE INTRATHECAL BACLOFEN THERAPY WITH INCREASE OF THE SPASTICITY AND HEMIPARESIS. THE X-RAYS SHOWED A CAUDAL DISLOCATION OF THE INTRATHECAL CATHETER. ON (B)(6) 2013 OPERATIVE REVISION OF THE INTRATHECAL CATHETER OCCURRED. THE NEW POST-OPERATIVE X-RAYS REVEALED THAT THE TIP OF THE INTRATHECAL CATHETER WAS AT THE SECOND THORACIC VERTEBRAE. POSTOPERATIVELY THE NEUROLOGICAL STATUS OF THE PATIENT RETURNED TO ITS PREVIOUS GOOD CONDITION. ON (B)(6) 2013 THE PATIENT HAD EMERGENCY ADMISSION TO THE HOSPITAL. THE NEUROLOGICAL STATUS WAS ACUTE N. ABDUZENSAND N. OCCULOMOTORIUS PARESIS ON THE LEFT SIDE, DIPLOPIA, HEADACHES, AND PAIN ON THE BACK OF THE NECK. THE SPASTICITY WAS UNAFFECTED. CARDIOPULMONARY WAS STABLE AND NO SIGNS OF BRADYCARDIA OR DYSPNEA. CT SCAN AND X-RAYS REVEALED MIGRATION OF THE CATHETER AT THE BASIS OF THE SKULL. THE REVISION ON (B)(6) 2013 FIXED THE INTRATHECAL CATHETER WITH MULTIPLE STITCHES AT THE MUSCLE FASCIA, WITH NO EVIDENCE OF LOOSENING OF THE STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6222 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R