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 2020-03-18 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[183965362]
Krause p, volzmann s, ewert s, kupsch a, schneider gh, kuhn aa. Long-term effects of bilateral pallidal deep brain stimulation in dystonia: a follow-up between 8 and 16 years. J neurol. 2020. 10. 1007/s00415-020-09745-z. Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender 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. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, implanted: unknown, udi#: asku. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183965363]
Summary: observational study to evaluate the long-term motor and non-motor effects of deep brain stimulation (dbs) of the globus pallidus internus (gpi) on medically refractory dystonia. Dystonia is a chronic disease affecting mainly young patients with a regular life expectancy and lifelong need for therapy. Pallidal dbs is an established/ treatment for severe isolated dystonia /ut long-term data are sparse. The authors considered 36 consecutive patients with isolated generalized (n = 14) and cervical/segmental (n = 22) dystonia operated at (b)(6)-university hospital between 2000 and 2007 in a retrospective analysis for long-term outcome of pallidal dbs. In 19 of these patients, we could analyze dystonic symptoms and disability rated by the burke? Fahn? Marsden dystonia rating scale (bfmdrs) at baseline, short-term (st-fu, range 3? 36 months) and long-term follow-up (lt-fu, range 93? 197 months). Quality of life and mood were evaluated using the sf36 and beck depression index (bdi) questionnaires. Patients reached an improvement in motor symptoms of 63. 8? 5. 7% (mean? Se) at st-fu and 67. 9? 6. 1% at lt-fu. Moreover, a significant and stable reduction in disability was shown following dbs (54. 2? 9. 4% at st-fu and 53. 8? 9. 2% at lt-fu). Bdi and sf36 had improved by 40% and 23%, respectively, at lt-fu (n = 14). Stimulation-induced adverse events included swallowing difficulties, dysarthria, and bradykinesia. Pulse generator (n = 3) and electrodes (n = 5) were revised in seven patients due to infection. Pallidal dbs is a safe and efficacious long-term treatment for dystonia with reported events: 1. One patient implanted with bilateral internal globus pallidus (gpi) deep brain stimulation (dbs) for dystonia committed suicide 2 years after bilateral pallidal stimulation. 2. One patient implanted with bilateral gpi-dbs for dystonia died in consequence of intracerebral bleeding following lysis therapy due to post-operative systemic pulmonary embolism two days after bilateral pallidal lead re-implantation. The following device information was identified in the literature article: ins models 37612, 37601, 7428 and lead models 3387 and 3389.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2020-00029 |
| MDR Report Key | 9848321 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-18 |
| 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 | 7000 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2020-03-18 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-18 |