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 2019-05-24 for ACTIVA 37601 manufactured by Medtronic Neuromodulation.
[146103650]
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 of the date that the article was accepted for publication as the event dates were not provided in the published literature. Description of problem or event: 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. Tyagi h, apergis-schoute am, akram h, et al. A randomized trial directly comparing ventral capsule and anteromedial subthalamic nucleus stimulation in obsessive-compulsive disorder: clinical and imaging evidence for dissociable effects. Biol psychiatry. 2019. 10. 1 016/j. Biopsych. 2019. 01. 017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146103651]
Tyagi h, apergis-schoute am, akram h, et al. "a randomized trial directly comparing ventral capsule and anteromedial subthalamic nucleus stimulation in obsessive-compulsive disorder: clinical and imaging evidence for dissociable effects. " biol psychiatry. 2019. 10. 1 016/j. Biopsych. 2019. 01. 017. Six patients with treatment-refractory ocd entered double-blind counterbalanced phases of 12-week anteromedial subthalamic nucleus ( amstn) or ventral capsule/ventral striatal (vc/vs) dbs, followed by 12-week open phases when amstn and vc/vs were stimulated together, in which optimal stimulation parameters were achieved and adjunctive inpatient cognitive behavioral therapy was delivered. Ocd and mood were assessed with standardized scales and cognitive flexibility with the cambridge neuropsychological test automated battery intra-extra dimensional set-shift task. Diffusion-weighted and intraoperative magnetic resonance imaging scans were performed for tractography from optimally activated electrode contacts. It was determined that both the vc/vs and amstn are effective targets for severe treatment-refractory ocd. Reported events: one patient experienced hypomania with alcohol excess and a minor hand fracture. One patient experienced urinary retention in the postoperative phase.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-01165 |
| MDR Report Key | 8641629 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2019-05-24 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| 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 | 2019-05-24 |