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 2019-03-06 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[138011446]
Age or 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. Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown. Product id: neu_ins_stimulator, serial/lot #: unknown. Zhang c, deng z, pan y, zhang, j. , zeljic, k. , jin, h. , stelt, o. , gong, h. , zhan, s. , li, d. , sun, b. Pallidal deep brain stimulation combined with capsulotomy for tourette's syndrome with psychiatric comorbidity. J neurosurg. 2019: 1-9. Doi: 10. 3171/2018. 8. Jns181339. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138011447]
Summary: objective a current challenge is finding an effective and safe treatment for severely disabled patients with tourette? S syndrome (ts) and comorbid psychiatric disorders, in whom conventional treatments have failed. The authors aimed to evaluate the utility of globus pallidus internus deep brain stimulation (gpi-dbs) combined with bilateral anterior capsulotomy in treating these clinically challenging patients. Methods the authors conducted a retrospective review of the clinical history and outcomes of 10 severely disabled patients with treatment-refractory ts and a psychiatric comorbidity, who had undergone gpi-dbs combined with bilateral anterior capsulotomy in their hospital. At the time of surgery, patients presented mainly with obsessive-compulsive disorder and affective disorders. Clinical outcome assessments of tic and psychiatric symptoms, as well as of general adaptive functioning and quality of life, were performed at the time of surgery and at 6, 12, and between 24 and 96 months postsurgery. Results after surgery, all patients showed significant progressive improvements in tic and psychiatric symptoms, along with improvements in general adaptive functioning and quality of life. Tic alleviation reached 64% at 12 months and 77% at the last follow-up on the yale global tic severity scale. At the final follow-up, patients had functionally recovered and displayed no or only mild tic and psychiatric symptoms. All patients tolerated treatment reasonably well, with no serious side effects. Conclusions gpi-dbs combined with bilateral anterior capsulotomy seems to offer major clinical benefits to severely disabled patients with otherwise treatment-refractory ts and psychiatric comorbidities. Reported events: one patient who underwent bilateral globus pallidus internus (gpi) deep brain stimulation (dbs) and capsulotomy for tourette? S syndrome (ts) and comorbid psychiatric disorders, such as obsessive-compulsive disorder (ocd), depression, or anxiety experienced an extension wire related infection 27 months post-implant that led to a worsening of motor tics. The authors reported that this led to a hospital admission but that a satisfactory outcome was achieved after the hardware event was? Appropriately managed.? A patient who underwent bilateral gpi-dbs and capsulotomy for ts and comorbid psychiatric disorders, such as ocd, depression, or anxiety experienced a transient epileptic seizure 2-years after implant that was well controlled by depakine 500 mg/d. All patients were implanted with 3387 model leads and either activa pc 37601, rc 37612, or soletra 7426 model neurostimulators. It was not possible to ascertain 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 | 3007566237-2019-00553 |
| MDR Report Key | 8396263 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-06 |
| 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 | MFR |
| Date Received | 2019-03-06 |
| 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. Hospitalization; 2. Other | 2019-03-06 |