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 2019-02-26 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[137182656]
Age or date of birth: 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. Date of event: 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. Novais, f. , pestana, lc. , loureiro, s. , andrea, m. , figueira, ml. , pimentel, j. Predicting de novo psychopathology after epilepsy surgery: a 3-year cohort study. Epilepsy behav. 2018. Doi: 10. 1016/j. Yebeh. 2018. 11. 037. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137182657]
Summary: objective: the aim of this study was to determine the potential risk factors for de novo psychiatric syndromes after epilepsy surgery. Methods: refractory epilepsy surgery candidates were recruited from our refractory epilepsy reference centre. Psychiatric evaluations were made before surgery and every year, during a 3-year follow-up period. Demographic, psychiatric, and neurological data were recorded. The types of surgeries considered were resective surgery (resection of the epileptogenic zone) and palliative surgery (deep brain stimulation of the anterior nuclei of the thalamus (ant-dbs)). A survival analysis model was used to determine pre- and postsurgical predictors of de novo psychiatric events after surgery. Results: one hundred and six people with refractory epilepsy submitted to epilepsy surgery were included. Sixteen people (15%) developed psychiatric disorders that were never identified before surgery. Multilobar epileptogenic zone (p=0. 001) and dbs of the ant-dbs (p=0. 003) were found to be significant predictors of these events. Conclusion: people with more generalized epileptogenic activity and those who undergo ant-dbs seem to present an increased susceptibility for the development of mental disorders, after neurosurgical interventions, for the treatment of refractory epilepsy. People considered to be at higher risk should be submitted to more frequent routine psychiatric assessments. Reported event: 4 patients with anterior nucleus of the thalamus (ant) deep brain stimulation (dbs) for epilepsy experienced new psychiatric symptoms after implant surgery. Overall 16 patients who either went resective surgery or dbs experienced adverse events including 6 acute transient psychotic disorder, 9 with de novo depressive episodes, 2 manic episodes, and 1 de novo anxiety disorder. 4 patients reportedly experienced 2 events. The authors noted that all events were transient and responded to pharmacotherapeutic intervention. It was not possible to ascertain 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 | 3007566237-2019-00466 |
| MDR Report Key | 8371348 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-02-07 |
| Date Added to Maude | 2019-02-26 |
| 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 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MBX |
| Date Received | 2019-02-26 |
| 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. Other | 2019-02-26 |