MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-02-06 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[178319710]
Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, product type: lead. 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 of publication of the article as the event dates were not provided in the published literature. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178319711]
Levi v, zorzi g, messina g, et al. Deep brain stimulation versus pallidotomy for status dystonicus: a single-center case series. J n eurosurg. 2019:1-11. 10. 3171/2019. 10. Jns191691. The aim of this study was to assess the clinical outcomes and surgery related complications of globus pallidus internus deep brain stimulation (gpi dbs) and pallidotomy for the treatment of drug-resistant sd. Fourteen patients were eligible for inclusion in the study. After surgery, the mean follow-up was 40. 6? 30 months. Dbs ended the dystonic storm in 87. 5% of cases (7/8), while pallidotomy had a success rate of 83. 3% (5/6). Reported events: three patient's had fatigue fractures of their right extracranial lead. They showed acute worsening of the baseline dystonia, and consequently underwent urgent lead replacement. It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event. See attached literature article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2020-00199 |
| MDR Report Key | 9678275 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Brand Name | IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2020-02-06 |
| 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 | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |