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 2019-01-17 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[133847614]
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 of publication of the article as the event dates were not provided in the published literature. Other relevant device(s) are: product id: 3389, serial/lot #: unknown; product id: 3389, serial/lot #: unknown; product id: 3389, serial/lot #: unknown. Herrman, h. , egge, a. , konglund, ae. , ramm-pettersen, j. , dietrichs, e. , tauboll, e. Anterior thalamic deep brain stimulation in refractory epilepsy: a randomized, double-blinded study. Acta neurol scand. 2018. Doi: 10. 1111/ane. 13047. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133847615]
Summary: objectives: the safety and effect on seizure frequency of anterior thalamic nucleus deep brain stimulation (ant-dbs) were studied in this prospective, randomized, double-blinded study. Patients were followed for 12 months. The first 6 months were blinded with regard to active stimulation or not. After 6 months, all patients received active stimulation. Material and methods- bilateral ant electrodes were implanted into 18 patients suffering from focal, pharmacoresistant epilepsy. Antiepileptic treatment was kept unchanged from three months prior to operation. The liverpool seizure severity scale (lsss) was used to measure the burden of epilepsy. Results: there was no significant difference between the 2 groups at the end of the blinded period at 6 months. However, when considering all patients and comparing 6 months of stimulation with baseline, there was a significant, 22% reduction in the frequency of all seizures (p=0. 009). Four patients had 50% reduction in total seizure frequency and 5 patients 50% reduction in focal seizures after 6 months of stimulation. No increased effect over time was shown. Lsss at 6 months compared to baseline showed no significant difference between the 2 groups, but a small, significant reduction in lsss was found when all patients had received stimulation for 6 months. Conclusions: our study supports results from earlier studies concerning dbs as a safe treatment option, with effects even in patients with severe, refractory epilepsy. However, our results are not as encouraging as those reported from many other, mainly unblinded, and open studies. Reported events: patient 2: a male patient with bilateral anterior nucleus of the thalamus (ant) deep brain stimulation (dbs) for epilepsy who also had a known history of depression and was randomized to be off-stimulation for the first 6 months of implant experienced short depressive episodes lasting a few hours at 3 months post-implant that they felt were different after dbs. At 6 months they reportedly experienced? Rapid depression? And suicidal thoughts. These symptoms were not reported at 9- or 12-months post-implant. Patient 2: a male patient with bilateral ant-dbs for epilepsy experienced twitches in their face and neck on the right side at 3 months that were reported as? Stimulation induced twitches on the right side of their head, neck and extremities? At 9-months. Diplopia, vertigo, and headache(s) were also reported at the 9-month follow-up, and? Decreased sensibility right side of the face? [sic]. The patient showed an increase in both fia and fbtc seizures. The voltage was reportedly lowered in response to the adverse effects described at 9 months, but they ultimately had the left lead replaced due to the lead being placed too close to the internal capsule, which they stated was the cause of the twitches? Every 6th minute? When the stimulation was on. Patient 9: a female patient with bilateral ant-dbs for epilepsy experienced transient left central facial paresis and dysarthria 3 days after implant. Ct scans showed evidence of a potential infarction around the right sided electrode. The patient? S symptoms remitted spontaneously within a week and ct + mri were confirmed to have returned to normal. All patients were implanted with 3389 model leads. It was not possible to ascertain any additional 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 | 3007566237-2019-00173 |
| MDR Report Key | 8257585 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-17 |
| 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 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MBX |
| Date Received | 2019-01-17 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| 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. Life Threatening; 2. Required No Informationntervention | 2019-01-17 |