MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Seizures (2063); Therapeutic Effects, Unexpected (2099); Impaired Healing (2378)

Event Date 05/22/2016

Event Type  Injury  

Manufacturer Narrative

Pt age: this value is the average age of the patients reported in the article as specific patients could not be identified.Pt sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Concomitant medical products: product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_ins_stimulator, product type: implantable neurostimulator.Product id neu_unknown_lead, product type: lead.Note, the second article cited, which contained the event information that made the file reportable, was received on 2016-09-01, after the initial article, which itself did not contain reportable information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Koy, a., timmermann, l.Deep brain stimulation in cerebral palsy: challenges and opportunities.European journal of paediatric neurology : ejpn : official journal of the european paediatric neurology society.2016.1090.(1-4).Doi: 10.1016/j.Ejpn.2016.05.015.Summary: cerebral palsy (cp) is the most common cause for acquired dystonia in childhood.Pharmacological treatment is often unsatisfactory and side effects are frequently dose-limiting.Data on outcome of dbs in paediatric patients with dyskinetic cp is very limited and heterogeneous.Reasons for the variability in responses are not entirely known yet.Interestingly, some cp-patients seem to improve subjectively on pallidal stimulation but without measurable changes in impairment scales.Besides dystonia scales, the use of sensitive age-dependent assessments tools is therefore reasonable to capture the full effect.As the course of disease duration as well as the age at operation seem to correlate with dbs outcome in patients with dystonia, dbs at an early stage of development might be beneficial for some of these patients.For the future, well-conducted trials as well as data collection in the international registry is of major importance to increase knowledge about dbs in cp patients, especially those implanted at a young age.Furthermore, selection criteria and guidelines or treatment standards are needed to improve the service for children with dyskinetic cp e especially in light of unsatisfactory medical treatment options.Koy a, et al., german registry of paediatric deep brain stimulation in patients with childhood-onset dystonia (gepestim), european journal of paediatric neurology (2016), 10.1016/j.Ejpn.2016.05.023.Summary: background: data on paediatric deep brain stimulation (dbs) is limited, especially for longterm outcomes, because of small numbers in single center series and lack of systematic multi-center trials.Objectives: we seek to systematically evaluate the clinical outcome of paediatric patients undergoing dbs.Methods: a german registry on paediatric dbs (gepestim) was created to collect data of patients with dystonia undergoing dbs up to the age of 18 years.Patients were divided into three groups according to etiology (group 1 inherited, group 2 acquired, and group 3 idiopathic dystonia).Reported events: approx 2 patients with deep brain stimulation (dbs) for dystonia experienced infection/healing problems that required implantable neurostimulator (ins) replacement.The authors noted that several different pathogens were documented, including: staphylococcus aureus, staphylococcus epidermidis, and pseudomonas aeruginosa.However, it remains unclear which pathogen was found in which patient; approx 4 patients with dbs for dystonia experienced an infection that led to the dbs system being explanted.The authors noted that several different pathogens were documented, including: staphylococcus aureus, staphylococcus epidermidis, and pseudomonas aeruginosa.However, it remains unclear which pathogen was found in which patient; approx 1 patient with dbs for dystonia experienced an infection/healing problems that were described as ¿reversible.¿ the authors noted that several different pathogens were documented, including: staphylococcus aureus, staphylococcus epidermidis, and pseudomonas aeruginosa.However, it remains unclear which pathogen was found in which patient; approx 1 patient with dbs for dystonia experienced reversible ¿disease-related¿ increased seizure frequency; approx 1 patient with dbs for dystonia reportedly failed to adequately recharge their ins, resulting in ¿irreversible¿ battery discharge that required ins replacement; approx 2 patients with dbs for dystonia experienced an ¿irreversible.Technical defect¿ that required ins replacement; approx 2 patients with dbs for dystonia experienced a lack of effect that led to the dbs system being explanted; approx 2 patients with dbs for dystonia experienced malposition or dislocation of the device that led to the dbs system being explanted; approx 3 patients with dbs for dystonia underwent a total of 4 lead revisions due to dislocation or ¿technical defect.¿ the authors reported that 12 patients received a rechargeable implantable neurostimulator (ins), whereas 27 patients were implanted by a non-rechargeable ins.However, it was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5966872
• MDR Text Key: 55261231
• Report Number: 3007566237-2016-03330
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: 09/01/2016
• Supplement Dates FDA Received: 09/25/2017
• 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): Other; Required Intervention
• Patient Age: 13 YR