MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-07-02 for NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[112992422]
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. Section d information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: canaz, h. , karalok, i. , topcular, b. , agaoglu, m. , yapici, z. , aydin, s. Dbs in pediatric patients: institutional experience. Childs nerv syst. 2018. Doi: 10. 1007/s00381-018-3839-1. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112992423]
Summary: introduction dbs is initially used for treatment of essential tremor and parkinson? S disease in adults. In 1996, a child with severe life-threatening dystonia was offered dbs to the internal globus pallidus (gpi) with lasting efficacy at 20 years. Since that time, increasing number of children benefited from dbs. Patients and methods we retrospectively evaluated our database of patients who underwent dbs from 2011 to 2017. All patients = 17 years of age at the time of implantation of dbs were included in this series. Subjective benefit rating scale (sbrs), hoehn yahr scale (hys), fahn marsden rating scale (fmrs), clinical global impressions scales (cgi), and yale global tic severity scale (ygt) were used to evaluate clinical outcome. Results between may 2014 and october 2017, 11 children underwent dbs procedure in our institution. Six of them were female and five of them were male. Mean age at surgery was 11. 8? 4. 06 years (range 5? 17 years). In our series, four patients had primary dystonia (pdy) (36. 3%), three patients had secondary dystonia (sdy) (27. 2%), two patients had jp (18. 1%), and two patients had tourette syndrome (ts) (18. 1%). Two jp patients under went bilateral stn dbs while the other nine patients underwent bilateral gpi dbs. Sbrs scores were 1. 75? 0. 5 for patients with pdy, 3? 0 for patients with jp, 2. 5? 0. 7 for patients with ts, and 2? 1 for patients with sdy. Mean fmrs reduction rate was 40. 5 for patients with dystonia. Significant improvement was also defined in patients with ts and jp after dbs. None of the patients experienced any intracerebral hemorrhage or other serious adverse neurological effect related to the dbs. Wound complications occurred in two patients. Conclusion there are many literatures that support dbs as a treatment option for pediatric patients with medically refractory neurological disorders. Dbs has replaced ablative procedures as a treatment of choice not only for adult patients, but also for pediatric patients. Wound-related complications still remain the most common problem in pediatric patients. Development of smaller and more flexible hardware will improve quality of children? S life and minimize wound-related complications in the future. Reported events: patient 8: a (b)(6)-year-old male patient with bilateral globus pallidusinternus (gpi) deep brain stimulation (dbs) for tourette syndrome experienced? Head skin? Erosion over the connection point of the leads. Related to this it was noted that the patient experienced t witching due to their ts. Infection was diagnosed so the system was totally removed. Escherichia coli was cultured. The dbs system was ultimately reinserted after antibiotic therapy was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-01956 |
| MDR Report Key | 7657453 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MFR |
| Date Received | 2018-07-02 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-02 |