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 2018-06-27 for ACTIVA 37612 manufactured by Medtronic Neuromodulation.
[112540739]
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. 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. Fitzgerald, pb, segrave, r, richardson, ke, knox, la. , herring, s. , daskalakis, zj. , bittar, rg. A pilot study of bed nucleus of the stria terminalis deep brain stimulation in treatment-resistant depression. Brain stimul. 2018. Doi: 10. 1016/j. Brs. 2018. 04. 013. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[112540740]
Summary: studies are increasingly investigating the therapeutic effects of deep brain stimulation (dbs) applied to a variety of brain regions in the treatment of patients with highly treatment refractory depression. Limited research to date has investigated the therapeutic potential of dbs applied to the bed nucleus of stria terminalis (bnst). Objective: the aim of this study was to explore the therapeutic potential of dbs applied to the bnst. Method: five patients with highly treatment resistant depression underwent dbs to the bnst in an open label case series design. Results: bnst dbs resulted in sustained remission of depression in two of the five patients, provided substantial therapeutic improvement two further patients, and had minimal antidepressant effect for the final patient. There were no operative complications and stimulation related side effects were limited and reversible with adjustment of stimulation. However, the time to achieve and complexity of programming required to achieve optimal therapeutic outcomes varied substantially between patients. Conclusion: dbs applied to the bnst as therapeutic potential in patients with highly refractory depression and warrants exploration in larger clinical studies. Reported events: 1. A female patient with bilateral deep brain stimulation (dbs) of the bed nucleus of the stria terminalis (bnst) for depression was a non-responder to stimulation therapy took an overdose with some degree of suicidal intent. The attempt did not occur within 2 weeks of a stimulation adjustment and did not appear to be related to stimulation induced effects. The patient experienced no persistent adverse consequences as a result. However, their electrodes were eventually explanted and new electrodes implanted targeting the subgenual anterior cingulate. They subsequently committed suicide while undergoing open label treatment at the second dbs stimulation target. Patients were implanted with 3387 model leads and 37612 activa rc neurostimulators. It was not possible to ascertain any other 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 | 3007566237-2018-01917 |
| MDR Report Key | 7644006 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-05-30 |
| Date Added to Maude | 2018-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2018-06-27 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| 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. Death | 2018-06-27 |