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 2020-02-11 for ACTIVA 37601 manufactured by Rice Creek Mfg.
[182909837]
(b)(6). Long versus short pulse width subcallosal cingulate stimulation for treatment-resistant depression: a randomised, double-blind, crossover trial. Lancet psychiatry. 2020;7(1):29-40. 10. 1016/s2215-0366(19)30415-8 a2: this value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Please note that this date is based off of the date that the article was accepted for publication as the publication date and event dates were not provided in the published literature. 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. D2/pma: selected mfr and h050003 as the patients in this study were implanted for a psychiatric indication. Depression is an off-label indication for use.
Patient Sequence No: 1, Text Type: N, H10
[182909838]
Summary: stimulation adjustment is required to optimize outcomes of deep brain stimulation (dbs) for treatment resistant depression, but controlled data for ideal stimulation parameters are poor or insufficient. The authors aimed to establish the efficacy and safety of short pulse width (spw) and long pulse width (lpw) subcallosal cingulate dbs in depression. The authors did a double-blind, randomized, crossover trial in an academic hospital in (b)(6). Patients had dsm iv-defined major depressive disorder and bipolar depression ((20? 70 years old, both sexes) and did not respond to treatment for more than 1 year, with a score of 20 or more on the 17-item hamilton depression rating scale (hdrs) at recruitment. Patients underwent bilateral dbs implantation into the subcallosal cingulate white matter using diffusion tensor imaging tractography. Patients were randomly assigned 1:1 without stratification using a computerized list generator to receive either spw (90? S) or lpw (210? 450? S) stimulation for 6 months. Patients and the clinician assessing outcomes were masked to the stimulation group. Keeping frequency constant (130 hz), either pulse width or voltage was increased monthly, based on response using the hdrs. Patients who did not respond to treatment (<(><<)>50% reduction in hdrs from baseline) at 6 months crossed over to the opposite stimulation for another 6 months. All patients received individualized cognitive behavioral therapy (cbt) for 12 weeks. The primary outcome was change in hdrs at 6 months and 12 months using intention-to-treat analysis. Between dec 5, 2013, and sept 30, 2016, of 225 patients screened for eligibility, 23 patients were selected for dbs surgery. After one patient withdrew, 22 (mean age 46? 4 years, sem 3? 1; 10 [45%] female, 12 [55%] male) were randomly assigned, ten (45%) to lpw stimulation and 12 (55%) to spw stimulation. Patients were followed up at 6 months and 12 months. There was a significant reduction in hdrs scores (p<(><<)>0? 0001) with no difference between spw and lpw groups (p=0? 54) in the randomization phase at 6 months. Crossov er groups did not show a significant decrease in hdrs within groups (p=0? 15) and between groups (p=0? 21) from 6? 12 months. Adverse events were equal between groups. Worsening anxiety and depression were the most common psychological adverse events. One patient in the spw group died by suicide. Interpretation both lpw and spw stimulation of subcallosal cingulate white matter tracts carried similar risks and were equally effective in reducing depressive symptoms, suggesting a role for both pulse width and amplitude titration in optimizing clinical outcomes in patients with treatment-resistant depression. Reported events: 1. Two patients implanted with bilateral deep brain stimulation (dbs) for treatment resistant depression experienced stinging/burning at ins site. The following device specifics were identified in the literature article: ins model 37601 and lead model 3387.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2020-00020 |
| MDR Report Key | 9696341 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-11 |
| 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 | RICE CREEK MFG |
| Manufacturer Street | 7000 CENTRAL AVE NE |
| Manufacturer City | FRIDLEY MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| 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 | 2020-02-11 |
| 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 | RICE CREEK MFG |
| Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |