BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3830858 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01433
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AGE REFLECTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    YARDLEY, M., KEENAN, L., FLISHER, L., BROOME, K., BUCHANAN, K., STEVENSON, V., FARRELL, R. LONG-TERM EFFICACY OF INTRATHECAL BACLOFEN TO MANAGE SEVERE SPASTICITY IN PEOPLE WITH MULTIPLE SCLEROSIS. MULT SCLER. 2013;19(11):523-. SUMMARY: THE OBJECTIVE WAS TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF INTRATHECAL BACLOFEN THERAPY TO TREAT MULTIPLE SCLEROSIS-RELATED SPASTICITY. THIS INCLUDED ALL SUBJECTS WHO PROCEEDED WITH PUMP INSERTION BETWEEN 1997 -2013. DATA INCLUDED PATIENT DEMOGRAPHICS, SPASTICITY SCORES (STIFFNESS NRS, ASHWORTH), SPASM SCORE (PENN SCORE), PAIN (VAS), PASSIVE RANGE OF MOVEMENT, MOBILITY / TRANSFERS , PRIOR ANTI-SPASTICITY MEDICATION, ITB TRIAL, PUMP INSERTION AND LONG TERM OUTCOMES. 71 SUBJECTS WERE INCLUDED, 55 FEMALES AND 16 MALES. MEAN AGE WAS 52 YEARS (RANGE 34-74), 36 HAD SPMS, 13 PPMS AND 22 WERE UNDEFINED PROGRESSIVE MS. MEAN DISEASE DURATION WAS 19.9 YEARS (6 ¿ 40) AT THE TIME OF ITB TRIAL. FOURTEEN SUBJECTS WERE RECEIVING DISEASE MODIFYING TREATMENT AND ALL WERE ON ORAL AGENTS FOR SPASTICITY. PRE TRIAL STIFFNESS NRS 8.3 (2 ¿ 10), PAIN NRS 5.3 (0 ¿ 10), COMFORT 6.5 (0.5 ¿ 10), MEAN PENN SPASM SCORE WAS 3.679. POST ITB STIFFNESS NRS 2.7 (0 ¿ 8), PAIN 1.7 (0 ¿ 8), COMFORT 2.03 (0 ¿ 7), PENN SPASM SCORE WAS 1.232. PRE TRIAL ASHWORTH SCO RES WERE = 2 IN MORE THAN 2 MUSCLE GROUPS, WITH MEAN POST TRIAL SCORES <(><<)> 1 IN MOST SUBJECTS. POST IMPLANT ITB DOSE 133.6 G/DAY (25 ¿ 380G) AND 56 SUBJECTS DISCONTINUED CONCOMITANT ORAL TREATMENT. MEAN FOLLOW UP WAS 3.54 YEARS (3 MONTHS ¿ 18 YEARS). SYMPTOM ATIC RESPONSE TO TREATMENT WAS MAINTAINED, WITH CONTINUED GAINS IN PROM, DOSE OF ITB INCREASED GRADUALLY DURING THIS PERIOD. COMPLICATIONS RELATED TO PUMP IMPLANT INCLUDED SEVERE LOW PRESSURE HEADACHE (N = 1), HAEMATOMA REQUIRING INTERVENTION (N = 2), DELIRIUM (N = 1). DURING FOLLOW UP 10 SUBJECTS EXPERIENCED CATHETER DYSFUNCTION REQUIRING REPLACEMENT AND 2 EXPERIENCED PUMP MALFUNCTION. ITB IS AN EFFECTIVE LONG TERM TREATMENT OPTION FOR PEOPLE WITH SEVERE SPASTICITY CAUSED BY MS, REDUCING STIFFNESS, PAIN, SPASMS AND MAINTAINING OR INCREASING RANGE OF MOVEMENT IN THE LOWER LIMBS. ITS USE ALSO REDUCES THE NEED FOR ORALLY ADMINISTERED TREATMENTS AND THUS REDUCES SYSTEMIC SIDE EFFECTS. REPORTED EVENTS: -TWO PATIENTS EXPERIENCED HAEMATOMAS REQUIRING INTERVENTION. -ONE PATENT EXPERIENCED DELIRIUM. -TEN PATIENTS EXPERIENCED CATHETER DYSFUNCTION REQUIRING REPLACEMENT. -TWO PATIENTS EXPERIENCED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307918 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention