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 2018-04-04 for ACTIVA PRIMARY CELL WITH SENSING 37604 manufactured by Medtronic Neuromodulation.
[104821981]
Age/date of birth. This value is the average age of the patients reported in the article as specific patients could not be identified. Sex. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. 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. The main component of the system. Other relevant device(s) are: product id: 3387, serial/lot #: unknown. Full citation:choi, ks. , noecker, am. , riva-posse, p. , rajendra, jk. , gross, re. , mayberg, hs. , mcintyre,cc. Impact of brain shift on subcallosal cingulate deep brain stimulation. Brain stimul. 2018;11(2):445-453. Doi: 10. 1016/j. Brs. 2017. 12. 001. (b)(4) used for report of "total mean pneumocephalus volume was 1770? 1185 mm3; brain shift". If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[104821982]
Summary: background: deep brain stimulation (dbs) of the subcallosal cingulate (scc) is an emerging experimental therapy for treatment-resistant depression. New developments in scc dbs surgical targeting are focused on identifying specific axonal pathways for stimulation that are estimated from preoperatively collected diffusion-weighted imaging (dwi) data. However, brain shift induced by opening burr holes in the skull may alter the position of the target pathways. Objectives: quantify the effect of electrode location deviations on tractographic representations for stimulating the target pathways using longitudinal clinical imaging datasets. Methods: preoperative mri and dwi data (planned) were coregistered with postoperative mri (1 day, near-term) and ct (3 weeks, long-term) data. Brain shift was measured with anatomical control points. Electrode models corresponding to the planned, near-term, and long-term locations were defined in each hemisphere of 15 patients. Tractography analyses were performed using estimated stimulation volumes as seeds centered on the different electrode positions. Results: mean brain shift of 2. 2 mm was observed in the near-term for the frontal pole, which resolved in the long-term. However, electrode displacements from the planned stereotactic target location were observed in the anterior-superior direction in both the near-term (mean left electrode shift: 0. 43 mm, mean right electrode shift: 0. 99 mm) and long-term (mean left electrode shift: 1. 02 mm, mean right electrode shift: 1. 47 mm). Dbs electrodes implanted in the right hemisphere (second-side operated) were more displaced from the plan than those in the left hemisphere. These displacements resulted in 3. 6% decrease in pathway activation between the electrode and the ventral striatum, but 2. 7% increase in the frontal pole connection, compared to the plan. Remitters from six-month chronic stimulation had less variance in pathway activation patterns than the n on-remitters. Conclusions: brain shift is an important concern for scc dbs surgical targeting and can impact connectomic analyses. Reported events: the authors reported that on average patients with deep brain stimulation (dbs) of the subcallosal cingulate (scc) displayed significant brain shift in the frontal pole, which was accompanied by pneumocephalus based on mr images. The brain shift was reportedly posterior and inferior, coinciding with the expected effects of gravity and in the range of 0-5 mm with an average of 2. 2? 1. 56 mm. The total mean pneumocephalus volume was 1770? 1185 mm3. The left and right volumes were 528? 679 mm3 and 1239? 1101 mm3, respectively. Notably, the right side was always the second to be implanted. Comparing the 1-day postoperative and 3-weeks postoperative electrode locations compared to preoperative planned electrode location a significant displacement in the anterior direction was observed: in the left hemisphere on the long-term images (mean shift = 1. 02 mm) relative to both the planned and near-term images (mean shift = 0. 43 mm). There was also significant displacement of the electrode in the right in the anterior and superior directions was noted in the right hemisphere in the long-term images (mean shift = 1. 47 mm) relative to the right planned and near-term location (mean shift = 0. 99 mm). Using probabilistic tractography the authors estimated that these electrode? Displacements? Resulted in a 3. 6% decrease in pathway activation between the electrode and ventral striatum and a 2. 7% increase in the frontal pole connection compared to plan. They noted that despite this the overall pathway activation pattern the overall pathway activation pattern maintained the intended scc dbs? Tractography blueprint? At each of the available time points. The brain shift reportedly resolved in the long term. 6 patients in 'cohort 2' were reportedly implanted with 37604 activa pc+s neurostimulators and 3387 model leads, however it was not possible to ascertain any additional specific device information from the article (i. E. Serial/lot numbers) or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-00979 |
| MDR Report Key | 7397830 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-04-04 |
| 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 | 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 PRIMARY CELL WITH SENSING |
| Product Code | MFR |
| Date Received | 2018-04-04 |
| Model Number | 37604 |
| Catalog Number | 37604 |
| 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 | 2018-04-04 |