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 2019-04-24 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[143040212]
This value is the average age of the patients reported in the article as specific patients could not be identified. There were 6 male and 6 female patients in the dbs cohort. Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature. The device was used for an off label indication; kim, jh. , jung, ny. , chang, ws. , jung, hh. , cho, sr. , chang, jw. Intrathecal baclofen pump versus globus pallidus interna deep brain stimulation in adult patients with severe cerebral palsy. World neurosurgery. 2019. Doi: 10. 1016/j. Wneu. 2019. 02. 092. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143040213]
Summary: there is no consensus on a standardized approach to spasticity or dystonia management of cerebral palsy (cp). This study aimed to investigate clinical outcomes and compare therapeutic responses for pallidal stimulation versus intrathecal baclofen (itb) therapy in adult patients with severe cp. Methods we retrospectively reviewed cp patients treated with deep brain stimulation (dbs) of the globus pallidus internus (gpi) or implantation of itb pump between june 2003 and april 2017. Patients were included if they were clinically diagnosed with medically intractable cerebral palsy and had >12 months of post-procedural follow-up data. Patients were assessed before and 12 months post-treatment using the visual analogue scale, burke-fahn-marsden dystonia rating scale, self-rating improvement scale, and 36-item short form general health survey questionnaire. Results patients (n=22) were divided into gpi dbs (n=12), and itb therapy (n=10) groups. For the burke-fahn-marsden dystonia rating scale, dbs group movement scores and itb group disability scores were significantly improved post-treatment. Although visual analogue scales did not differ between groups, self-rating improvement scores differed significantly between groups. For quality of life, physical functioning, body pain, vitality, social functioning, and mental health significantly improved in itb group 12 months post-treatment compared to those of preoperative period. Only mental health differed significantly between groups. Conclusions. Despite retrospective design and relatively low number of cases, this study indicated that itb therapy was less invasive and more effective in improving the quality of life compared to gpi dbs. Itb therapy should be considered an alternative treatment for patients with severe cp. Reported events: 1 patient with globus pallidus internus (gpi) deep brain stimulation (dbs) for pain and secondary dystonia associated with cerebral palsy (cp) attempted suicide 1-month post-implant because? The outcome was not as expected.? All dbs patients were implanted with 3387 model leads. It was not possible to ascertain any other specific device information from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00941 |
| MDR Report Key | 8547536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-04-19 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Brand Name | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2019-04-24 |
| 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. Life Threatening | 2019-04-24 |