BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4570607 · Received March 4, 2015

    Report

    Report Number
    3007566237-2015-00520
    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

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (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 (B)(6). 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 EVENT: ONE (B)(6) MALE PATIENT HAD THE CATHETER REPOSITIONED TO T-12 AT AN OPERATION CONCERNING CATHETER COMPLICATIONS. IT WAS NOT STATED WHICH TYPE OF COMPLICATION THIS PATIENT EXPERIENCED. SEE ATTACHED LITERATURE ARTICLE IN MANUFACTURER REPORT #3007566237-2015-00519.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151432 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention