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 2018-02-08 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[99560634]
This value is the average age of the patients reported in the article as specific patients could not be identified. 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. The device was used in an off-label manner; the main component of one of the systems involved in the reported events; other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead. Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator. Raymaekers, s. , luyten, l. , bervoets, c. , gabriels, l. , nuttin, b. Deep brain stimulation for treatment-resistant major depressive disorder: a comparison of two targets and long-term follow-up. Transl psychiatry. 2017;7(10):e1251. Doi:10. 1038/tp. 2017. 66. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99560635]
Summary: we previously found that electrical stimulation in the anterior limb of the internal capsule/bed nucleus of the stria terminalis (ic/bst) alleviates depressive symptoms in severe treatment-resistant obsessive-compulsive disorder (ocd) patients. Here we tested the hypothesis that electrical stimulation in either ic/bst or in the inferior thalamic peduncle (itp) effectively reduces depressive symptoms in treatment-resistant major depressive disorder (trd). In a double-blind crossover design, the effects of electrical stimulation at both targets were compared in trd patients. The 17-item hamilton depression rating scale (ham-d) was the primary outcome measure. During the first crossover, patients received ic/bst stimulation versus no stimulation in random order (2? 1 weeks). During the second crossover (3? 2 months), patients received ic/bst versus itp versus no stimulation. Patients and evaluators were blinded for stimulation conditions. All patients (n = 7) were followed up for at least 3 years (3? 8 years) after implantation. Six patients completed the first crossover and five patients completed the second. During the first crossover, mean (s. D. ) ham-d scores were 21. 5 (2. 7) for no stimulation and 11. 5 (8. 8) for ic/bst stimulation. During the second crossover, ham-d scores were 15. 4 (7. 5) for no stimulation, 7. 6 (3. 8) for ic/bst stimulation and 11. 2 (7. 5) for itp stimulation. The final sample size was too small to statistically analyze this second crossover. At last follow-up, only one patient preferred itp over ic/bst stimulation. Two patients, with a history of suicide attempts before implantation, committed suicide during the follow-up phases of this study. Our data indicate that, in the long term, both itp and ic/bst stimulation may alleviate depressive symptoms in patients suffering from trd. Reported events: pli 10: an unknown number of patients with deep brain stimulation (dbs) leads bilaterally targeting the internal capsule/bed nucleus of the stria terminalis (ic/bst) and the inferior thalamic peduncle (itp) for treatment resistant depression (trd) experienced cognitive/behavioral adverse events that were reportedly stimulation induced. Under stimulation of the ic/bst the authors reported: 1 instance of intrusive thoughts about violent suicide; 1 instance of hearing the voice of their deceased sister; 1 instance of a feeling of derealization; 1 instance of disruption of social skills; 1 instance of increased impulsivity; and 2 instances of concentration difficulties. Under stimulation of the itp the authors reported: 1 instance of obsessive counting; and 1 instance of compulsive stealing. Pli 20: a patient who received 4 dbs leads bilaterally targeting the ic/bst and the itp for trd reportedly had a surgery/device related adverse event relating to their leads being? Conversely labelled? Resulting in the itp being stimulated when they expected the ic/bst to be stimulated. This reportedly led to an additional surgical procedure. Pli 30: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced damage of the internal capsule electrode. This reportedly led to an additional surgical procedure. Pli 40: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced an infection around the stereotactic frame attachment site. Pli 50: 2 patients with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced an infection around the implantable neurostimulator (ins). This reportedly led to an additional surgical procedure. Pli 60: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced sleep apnea that was reportedly induced by stimulation of the itp. Pli 70: a patient with dbs leads bilaterally targeting the ic/bst and the itp for trd experienced urinary retention that was reportedly induced by stimulation of the ic/bst. The authors reported that patients were eventually implanted with model 37612 activa rc's, however the original ins models were not stated. They also reported patients 1-5 received 3387 and patients 6-7 received 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 | 3007566237-2018-00407 |
| MDR Report Key | 7253194 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-02-08 |
| 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 | 2018-02-08 |
| 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. Other; 3. Required No Informationntervention | 2018-02-08 |