BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4570335 · Received March 4, 2015

    Report

    Report Number
    3007566237-2015-00519
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    February 4, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OVERGÅRD, T.M., KJÆRSGAARD-HANSEN, L., SØE, M., OVE ILLUM, N. POSITIVE EXPERIENCE WITH INTRATHECAL BACLOFEN TREATMENT IN CHILDREN WITH SEVERE CEREBRAL PALSY. DANISH MEDICAL JOURNAL. 2015; 62(1):A4999. SUMMARY: TREATMENT OF SEVERE SPASTICITY AND DYSTONIA WITH INTRATHECAL BACLOFEN (ITB) IN CHILDREN HAS BEEN SHOWN TO BE EFFECTIVE AND HAS THEREFORE BEEN EMPLOYED IN THE REGION OF SOUTHERN DENMARK. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ANALYZE THE EFFICACY AND ADVERSE EVENTS SINCE ITB WAS INTRODUCED IN 2003. A TOTAL OF 46 CHILDREN WHO HAD A BACLOFEN PUMP FROM APRIL 2003 TO JANUARY 2013 WERE INCLUDED. THE CHILDREN¿S MEDICAL RECORDS WERE REVIEWED AND CLINICAL CHARACTERISTICS, EFFICACY, AND ADVERSE EVENTS WERE REGISTERED. THE EFFICACY OF TREATMENT EXPERIENCED BY PARENTS WAS ASCERTAINED BY TELEPHONE INTERVIEWS, AND DATA WAS RATED ON A LIKERT SCALE RANGING FROM ONE TO FIVE, WHERE ONE WAS NO EFFECT AND FIVE WAS MARKED IMPROVEMENT. AFTER ITB, SPASTICITY WAS REDUCED FROM A MEDIAN OF FOUR TO TWO IN THE UPPER EXTREMITIES AND FROM A MEDIAN OF FOUR TO ONE IN THE LOWER EXTREMITIES. BACLOFEN INFUSION WAS 105.1-2,000 MICROGRAMS/DAY (MEAN 494.9 MICROGRAMS/DAY). ORAL BACLOFEN WAS REDUCED FROM 27.3 TO 17.7 MG/DAY AFTER ITB (P<(><<)>0.01). THE PARENTS¿ ASSESSMENT OF IMPROVEMENT IN WELL-BEING, FUNCTION, AND EASE OF CARE OF THEIR CHILD HAD A MEAN SCORE OF 3.7, 2.2, AND 3.4, RESPECTIVELY. 87.1% OF PARENTS STATED THAT ITB HAD BEEN WORTHWHILE, AND 90.3% WOULD RECOMMEND IT TO OTHER PARENTS. MOST INFECTIOUS AND MECHANICAL ADVERSE EVENTS WERE EXPERIENCED DURING THE FIRST 200 DAYS AFTER PUMP IMPLANTATION. THE TOTAL COMPLICATION RATE WAS 0.40 PER PUMP YEAR. ITB RESULTED IN REDUCED SPASTICITY IN CHILDREN WITH SEVERE SPASTICITY AND DYSTONIA, AND ITB COULD BE CONSIDERED SAFE. PARENTS' SATISFACTION WITH ITB WAS RATED AS GOOD AND MOST PARENTS WOULD RECOMMEND ITB TO OTHERS. REPORTED EVENTS: -FIVE PATIENTS EACH EXPERIENCED A HEMATOMA WITH A TOTAL OF THREE REOPERATIONS BEING PERFORMED. THE HEMATOMAS AT THE PUMP SITE OCCURRED SHORTLY AFTER OPERATION. FIVE PATIENTS EXPERIENCED A TOTAL OF EIGHT INFECTIONS OCCURRED AT THE PUMP OR IN THE BACK. ON AVERAGE, THE INFECTIONS WERE IDENTIFIED WITHIN TWO MONTHS OF IMPLANT. A TOTAL OF SEVEN REOPERATIONS WERE PERFORMED; SIX RESULTED IN THE PUMP BEING REMOVED, AND ONE LED TO THE REMOVAL OF ONLY THE CATHETER. THREE PATIENTS EXPERIENCED A CASE OF MENINGITIS. TEN PATIENTS EXPERIENCED A TOTAL OF FIFTEEN CEREBROSPINAL FLUID LEAKAGES WITH A TOTAL OF ELEVEN REOPERATIONS BEING PERFORMED. NINE PATIENTS EXPERIENCED A TOTAL OF FOURTEEN CATHETER COMPLICATIONS WITH A TOTAL OF FOURTEEN REOPERATIONS BEING PERFORMED. THERE WERE FIVE LESIONS, TWO CATHETER KINKS, ONE CASE OF THERE BEING NO PASSAGE THROUGH THE CATHETER, TWO CATHETER BREAKS, THREE CATHETER DISCONNECTIONS, AND ONE CATHETER DISLOCATION. TWO PATIENTS EXPERIENCED A PUMP MALFUNCTION, BOTH RESULTING IN THE REMOVAL OF THE PUMP. THIRTEEN PATIENTS EXPERIENCED A TOTAL OF FIFTEEN CASES OF BACLOFEN SIDE EFFECTS WITH A REOPERATION BEING PERFORMED FOR ONE CASE. THERE WERE NINE CASES OF OVERDOSAGE, THREE CASES OF WITHDRAWAL OR ABSTINENCE, AND THREE CASES OF UNDERDOSAGE. ONE PATIENT EXPERIENCED ADVERSE ADMINISTRATION OF A DOSE CAUSED BY CATHETER LEAKAGE THAT DEMANDED REOPERATION. THIS PATIENT HAD BEEN EXPERIENCING A HEADACHE OF LONG DURATION, WHICH RESOLVED AFTER REOPERATION. TWO PATIENTS EACH EXPERIENCED COMPLICATIONS CAUSED BY OTHER SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149915 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Required Intervention