MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Apnea (1720); Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Pneumonia (2011); Constipation (3274); Convulsion/Seizure (4406)

Event Date 04/06/2022

Event Type  Injury  

Event Description

Citation: bonouvrie la, haberfehlner h, becher jg, et al.Attainment of personal goals in the first year of intrathecal baclofen treatment in dyskinetic cerebral palsy: a prospective cohort study.Disabil rehabil.2022:1-8.10.1080/09638288.2022.2057600.Abstract: purpose: to assess attainment of individual treatment goals one year after intrathecal baclofen (itb) pump implantation in individuals with dyskinetic cerebral palsy (cp).Materials and methods: a multi-center prospective cohort study was conducted including 34 non-walking individuals with severe dyskinetic cp, classified as gross motor function classification system (gmfcs) iv/v, aged 4¿24 years, 12 months after pump implantation.The main outcome measure was goal attainment scaling (gas).Predictors of gas results were analyzed.Complications were registered systematically.Results: seventy-one percent of individuals with dyskinetic cp fully achieved one or more treatment goals.One or more treatment goals were partially achieved in 97% of individuals.Two factors were found to be associated with attainment of goals: dyskinesia impairment scale (dis) score at baseline and the difference in pain score between baseline and follow-up.These two variables explain 30% of the variance in the outcome.Conclusions: intrathecal baclofen is effective in achieving individual treatment goals in children and young adults with dyskinetic cp after nine to 12 months of itb treatment.A positive outcome on treatment goals is, for a small part, associated with higher severity of dystonia at baseline and with improvement of pain during treatment.Reported events: from the 36 eligible individuals, 34 were included in this study for follow up and analysis.Two individuals were not included because one individual never got a pump implanted because of severe illness after inclusion but prior to implantation, and in the second individual the pump was removed due to pump infection and was not reimplanted at a later moment in time.Nine individuals (26.5%) showed deterioration of one (n ¼ 6) or two (n ¼ 3) goals.Four of these individuals showed at least partial achievement on the two other goals, and four others on one other goal.Only one individual showed overall deterioration and no improvement.Fourteen saes occurred in 11 of 34 individuals (32%) (table 2).Eight individuals experienced one sae, three experienced two saes.Of the 14 saes, there were three catheter related complications, two pump infections, and two temporary cerebrospinal fluid (csf) leaks.The catheter related complications and pump infections needed surgical intervention.Based on the sleep related questionnaires, seven of 34 individuals (19.4%) showed an increased risk for srbd compared to baseline, while four of 34 individuals (11.1%) showed a decreased risk for srbd.Other adverse events such as pneumonia, gastro-intestinal infection, obstipation, apnea, and seizures also occurred.These complications are probably not directly related to itb treatment but likely correlate to the overall health status of the severely affected children included in our trial.

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.This value reflects the weight of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Other relevant device(s) are: product id: 8780, serial/lot #: unknown.Product type: catheter.Citation: bonouvrie la, haberfehlner h, becher jg, et al.Attainment of personal goals in the first year of intrathecal baclofen treatment in dyskinetic cerebral palsy: a prospective cohort study.Disabil rehabil.2022:1-8.10.1080/09638288.2022.2057600.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14676578
• MDR Text Key: 294908616
• Report Number: 2182207-2022-01065
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 34 KG