MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-01-15 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[175180058]
Graat i, van rooijen g, mocking r, et al. Is deep brain stimulation effective and safe for patients with obsessive compulsive disorder and comorbid bipolar disorder? J affect disord. 2019;264:69-75. 10. 1016/j. Jad. 2019. 11. 152. Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown. It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event. This value is the average age of the patients reported in the article as specific patients could not be identified. Please note that the actual date of death was not provided in the literature article; this date is based on the date of article publication. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175180059]
Graat i, van rooijen g, mocking r, et al. Is deep brain stimulation effective and safe for patients with obsessive compulsive disorder and comorbid bipolar disorder? J affect disord. 2019;264:69-75. 10. 1016/j. Jad. 2019. 11. 152. Five consecutive patients suffering from treatment-refractory ocd with comorbid bd (i or ii) underwent dbs of the ventral anterior limb of the internal capsule (valic). This study examined effectiveness of dbs on symptoms of ocd and depression, using the yale-brown obsessive-compulsive scale (y-bocs) and hamilton depression rating scale (ham-d). Side-effects were also monitored, in particular dbs-induced (hypo)manic symptoms, using the young mania rating scale (ymrs). Reported events: two patients attempted suicide by means of overdosing. The events were deemed unlikely directly related to stimulation. In both patients suicidal ideations resolved without stimulation settings or medication changes, and there were no persevering adverse consequences. 3 patients were admitted at the psychiatric ward for monitoring of hypomanic symptoms during the first days or weeks of stimulation optimization. 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 | 3007566237-2020-00083 |
| MDR Report Key | 9592955 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-11-30 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Product Code | MFR |
| Date Received | 2020-01-15 |
| 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. Hospitalization; 2. Life Threatening | 2020-01-15 |