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 2016-12-16 for NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[62669925]
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. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[62669926]
Polosan, m. , chabardes, s. , bougerol, t. , ardouin, c. , pollak, p. , benabid, al. , krack, p. Long-term improvement in obsessions and c ompulsions with subthalamic stimulation. Neurology. 2016;87(17):1843-1844. Summary: obsessive-compulsive disorder (ocd) may be conceptualized as a disorder of self-control and behavioral inhibition. Recent studies suggested interest in deep brain stimulation (dbs) of different subcortical brain targets such as the nucleus accumbens, anterior internal capsule/ventral striatum, and subthalamic nucleus (stn) in severe, resistant ocd. Stn is a critical node of the indirect and hyperdirect basal ganglia? Thalamocortical circuit. Stn-dbs may release its function as a brake on behavioral programs, disinhibiting habitual responses and enabling more flexible goal-directed behavior control in ocd. Little is known about long-term outcome of stn-dbs in ocd. Based on experience in parkinson disease, stn-dbs can induce a change from apathetic to disinhibited behavior. This target has also a potential impact on addictions. (b)(4). Reported event: a (b)(6) man with bilateral subthalamic nucleus deep brain stimulation (stn-dbs) for the treatment of obsessive compulsive disorder (ocd) overall had a major improvement in ocd, anxiety and mood and they were able to reintegrate into their social, family and work life. The patient reportedly experienced a major improvement in preexisting suicidal ideas, but made 2 suicidal attempts? In a context of short, partial relapses? Where he stopped taking his medication in the first year of implant. Ultimately after 10 years of implant the authors reported robust improvement that the patient self-estimated to be 80% compared to baseline. 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
[100825485]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2016-04440 |
| MDR Report Key | 6182480 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-11-21 |
| Date Added to Maude | 2016-12-16 |
| 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 | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| 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 |
| Product Code | MFR |
| Date Received | 2016-12-16 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-12-16 |