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 2019-03-20 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[139414889]
This value is the average age of the patients reported in the article as specific patients could not be identified. The article reported that there were an even number 10 males and 10 females in the study cohort. 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_ins_stimulator, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown. Huys, d. , kohl, s. , baldermann, jc. , timmermann, l. , sturm, v. , visser-vandewalle, v. , kuhn, j. Open-label trial of anterior limb of internal capsule? Nucleus accumbens deep brain stimulation for obsessive-compulsive disorder: insights gained. Neurol neurosurg ps ychiatry. 2019;0:1? 8. Doi:10. 1136/jnnp-2018-318996. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139414890]
Summary: background for more than 15 years, deep brain stimulation (dbs) has served as a last-resort treatment for severe treatment-resistant obsessive-compulsive disorder (ocd). Methods from 2010 to 2016, 20 patients with ocd (10 men/10 women) were included in a single-centre trial with a naturalistic open-label design over 1 year to evaluate the effects of dbs in the anterior limb of the internal capsule and nucleus accumbens region (alic-nacc) on ocd symptoms, executive functions, and personality traits. Results a lic-nacc-dbs significantly decreased ocd symptoms (mean yale-brown obsessive compulsive scale reduction 33%, 40% full responders) and improves global functioning without loss of efficacy over 1 year. No significant changes were found in depressive or anxiety symptoms. Our study did not show any effect of alicnacc- dbs on personality traits or executive functions, and no potential outcome predictors were identified in a post hoc analysis. Other than several individual minor adverse events, alic-nacc-dbs has been shown to be saf e, but 35% of patients reported a sudden increase in anxiety and anhedonia after acute cessation of stimulation. Conclusions we conclude that alic-nacc-dbs is a well-tolerated and promising last-resort treatment option for ocd. The cause of variability in the outcome remains unclear, and the aspect of reversibility must be examined critically. The present data from one of the largest samples of patients with ocd treated with dbs thus far support the results of previous studies with smaller samples. Reported events: patient 15: a (b)(6) year-old male patient with bilateral deep brain stimulation (dbs) of the anterior limb of the internal capsule and nucleus accumbens region (alic-nacc) for obsessive compulsive disorder (ocd) experienced an infection of the implantable neurostimulator (ins) pocket that necessitated surgical replacement. A patient with bilateral dbs of the alic and nacc for ocd experienced a sudden increase in anxiety and anhedonia after acute cessation of stimulation, going so far as to report suicidal tendencies. These symptoms disappeared immediately upon resuming stimulation. The authors suggested cessation of stimulation was necessary at times for clinical care e. G. Ecg. Patient 12: a (b)(6) year-old female patient with bilateral dbs of the alic and nacc for ocd experienced pain due to cable traction that necessitated surgical replacement. All patients were implanted with either 3387 or 3389 model leads and 7426 soletra or 37601 activa pc neurostimulators. It was not possible to identify which specific devices were associated with any particular event, nor was it 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 | 3007566237-2019-00671 |
| MDR Report Key | 8438350 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-20 |
| 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 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MFR |
| Date Received | 2019-03-20 |
| 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 | 2019-03-20 |