MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2017-01-31 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[66170516]
Pt age: please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Pt gender: please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. Date of event: please note that this date is based off the date of publication of the article as the actual event date was not provided. Concomitant medical products: product id neu_ins_stimulator, product type implantable neurostimulator, quantiy: 16. 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
[66170517]
Fayad sm, guzick ag, reid am, mason dm, bertone a, foote kd, okun ms, goodman wk, ward he. Six-nine year follow-up of deep brain stimulation for obsessive-compulsive disorder. Plos one. 2016; 11(12): e0167875 doi: 10. 1371/journal. Pone. 0167875. Summary: deep brain stimulation (dbs) of the ventral capsule/ventral striatum (vc/vs) region has shown promise as a neurological intervention for adults with severe treatment-refractory obsessive-compulsive disorder (ocd). Pilot studies have revealed improvement in obsessive-compulsive symptoms and secondary outcomes following dbs. We sought to establish the long-term safety and effectiveness of dbs of the vc/vs for adults with ocd. Reported event: 1 patient with bilateral deep brain stimulation (dbs) for obsessive-compulsive disorder (ocd) experienced a serious adverse event. The patient was admitted to an inpatient psychiatric facility following a dbs settings adjustment within the first year post-implantation for worsening ocd. Once the settings were appropriately readjusted, the patient improved and was discharged. There was no specific device information provided.
Patient Sequence No: 1, Text Type: D, B5
[99020086]
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
| Report Number | 3007566237-2017-00397 |
| MDR Report Key | 6290125 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-31 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2017-01-31 |
| 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 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 |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MFR |
| Date Received | 2017-01-31 |
| 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. Hospitalization | 2017-01-31 |