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 2017-06-30 for NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[78900240]
Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.
Patient Sequence No: 1, Text Type: N, H10
[78900241]
Mulders, aep. , leentjens, afg. , schruers, k. , duits, a. , ackermans, l. , temel, y. Choreatic side-effects of deep brain stimulation of the anteromedial subthalamic nucleus for treatment-resistant obsessive-compulsive disorder: a case report. World neurosurg. 2017. Doi: 10. 1016/j. Wneu. 2017. 05. 067 summary: background: patients with treatment-resistant obsessive-compulsive disorder (ocd) are potential candidates for deep brain stimulation (dbs). The anteromedial subthalamic nucleus (stn) is amongst the most commonly used targets for dbs in ocd. Case description: we present a patient with a 30-year history of treatment-resistant ocd who underwent anteromedial stn-dbs. Despite a clear mood-enhancing effect, stimulation caused motor side-effects including bilateral hyperkinesia, dyskinesias and sudden large amplitude choreatic movements of arms and legs when stimulating at voltages above circa 1. 5v. Dbs at lower amplitudes and at other contact points failed to result in a significant reduction of obsessions and compulsions without inducing motor side-effects. Due to this limitation in programming options, we decided to re-operate and target the ventral capsule/ventral striatum (vc/vs), which resulted in a substantial reduction in key obsessive and compulsive symptoms without serious side-effects. Conclusion: choreatic movements and hemiballismus have previously been linked to stn dysfunction and have been incidentally reported as side-effect of dbs of the dorsolateral stn in parkinson's disease (pd). However, in pd, these side-effects were usually transient and rarely interfered with dbs programming. In our case, the motor side-effects were persistent and made optimal dbs programming impossible. To our knowledge such severe a nd persistent motor side effects have not yet been described for anteromedial stn-dbs. Reported events: a (b)(6) female patient who received bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn) for obsessive compulsive disorder (ocd) developed unexpected compulsive behavior towards their operation wounds, including scratching and itching, which the authors felt likely contributed to the development of a hardware infection. The infection was treated with removing the infected implantable neurostimulator (ins) and cables and antibiotic therapy. Two months later a new dbs was implanted and therapy reactivated. It was noted that the patient was implanted with 3389 model lead, but it was not possible to ascertain any further 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
[100965821]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02619 |
| MDR Report Key | 6682636 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-06-30 |
| 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 |
| Product Code | MFR |
| Date Received | 2017-06-30 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-06-30 |