BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 3490198 · Received November 26, 2013

    Report

    Report Number
    3007566237-2013-03857
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    June 23, 2013
    Report Date
    October 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AVERAGE AGE OF SUBJECTS WAS 21.1 YEARS. SUBJECTS WERE MAJORITY FEMALE WITH 9 FEMALES AND 8 MALES. THE ACTUAL EVENT DATE WAS NOT KNOWN. THIS DATE IS BASED ON THE DATE OF PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    VLES, G. F., SOUDANT, D. L., HOVING, M. A., VERMEULEN, R. J., BONOUVRIE, L. A., VAN OOSTENBRUGGE, R. J., VLES, J. S. H. LONG-TERM FOLLOW-UP ON CONTINUOUS INTRATHECAL BACLOFEN THERAPY IN NON-AMBULANT CHILDREN WITH INTRACTABLE SPASTIC CEREBRAL PALSY. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY : EJPN : OFFICIAL JOURNAL OF THE EUROPEAN PAEDIATRIC NEUROLOGY SOCIETY. 1090;2013 JUL 18. SUMMARY: LITTLE IS KNOWN ABOUT THE LONG-TERM EFFECTS OF CONTINUOUS INTRATHECAL BACLOFEN (CITB) THERAPY IN NON-AMBULANT CHILDREN WITH INTRACTABLE SPASTIC CEREBRAL PALSY (CP). THE OBJECTIVE WAS TO DETERMINE WHETHER SHORT-TERM BENEFICIAL EFFECTS OF CITB THERAPY ARE PRESENT AT THE LONG-TERM, AND WHETHER CAREGIVERS WOULD CHOOSE CITB THERAPY FOR THEIR CHILD AGAIN CONSIDERING THE ADVANTAGES AND DISADVANTAGES ENCOUNTERED OVER THE YEARS. LONG-TERM FOLLOW-UP DATA WERE OBTAINED OF THE CHILDREN WHOM HAD PREVIOUSLY PARTICIPATED IN A RCT ON CITB BY THE DUTCH STUDY GROUP ON SPASTICITY. QUALITY OF LIFE (QOL) WAS ASSESSED BY THE CHILD HEALTH QUESTIONNAIRE (CHQ), CURRENT SATISFACTION WITH CITB WAS MEASURED BY USE OF A VISUAL ANALOGUE SCALE REGARDING PREVIOUSLY SET TREATMENT GOALS, FUNCTIONING IN DAILY LIVING WAS DETERMINED BY A QUESTIONNAIRE CONCERNING FUNCTIONING OF THE CHILD, AND POSSIBLE DETRIMENTAL EFFECTS OF CITB THERAPY ENCOUNTERED OVER THE YEARS WERE NOTED. ALL DATA WERE ACQUIRED VIA INTERVIEW OF THE CAREGIVERS. ALL 17 CHILDREN OF THE FORMER TRIAL PARTICIPATED IN THIS STUDY. PREVIOUSLY IDENTIFIED SIGNIFICANT POSITIVE EFFECTS ON PAIN (CHQ 46.8 VS. 74.38, P ¼ 0.002; VAS 2.4 VS. 8.01, P ¼ 0.02), EASE OF CARE (VAS 2.0 VS. 7.26, P ¼ 0.00), AND MENTAL HEALTH (CHQ 67.2 VS. 75.94, P ¼ 0.010) WERE STILL PRESENT AT THE END OF THE TRIAL. NOVEL SIGNIFICANT POSITIVE EFFECTS WERE NOTED AT SIX TO NINE YEARS FOLLOW-UP, I.E. SIGNIFICANTLY IMPROVED SCORES ON THE PARENT IMPACT -EMOTIONAL SUBSCALE (CHQ 66.0 VS. 78.2, P ¼ 0.008), PARENT IMPACT E TIME SUBSCALE (CHQ 68.9 VS. 91.72, P ¼ 0.002), AND THE PHYSICAL SUMMARY (CHQ 17.6 VS. 27.4, P ¼ 0.019) COMPARED TO BASELINE. NINETY-FOUR PERCENT OF THE CAREGIVERS WOULD CHOOSE CITB TREATMENT AGAIN FOR THEIR CHILD AGAIN. THE BENEFICIAL EFFECTS OF CITB ARE PRESENT AT THE LONG TERM AND CAREGIVER SATISFACTION IS HIGH. REPORTED EVENTS: THERE WAS ONE CASE OF PUMP FAILURE. THERE WAS ONE CASE OF PUMP ¿SUBSIDENCE¿. THE CATHETER WAS TOO HIGH IN TWO CASES. THE CATHETER WAS TOO LOW IN ONE CASE. THE CATHETER WAS TOO SUPERFICIAL IN ONE CASE. THE CATHETER WAS OBSTRUCTED IN TWO CASES. THERE WERE 3 HOSPITALIZATIONS RELATED TO THE CONTINUOUS INTRATHECAL BACLOFEN THERAPY (UNSPECIFIED). THREE PATIENTS UNDERWENT SURGICAL CORRECTION OF SCOLIOSIS. ONE PATIENT UNDERWENT SURGERY TO LENGTHEN THE FIBULAR TENDONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615434 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Hospitalization| R UNKNOWN_CATHETER