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 2018-12-27 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[131592179]
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. Jarvenpaa, s. , peltola, j. , rainesalo, s. , leinonen, e. , lehtimaki, k. , jarventausta, k. Reversible psychiatric adverse effects related to deep brain stimulation of the anterior thalamus in patients with refractory epilepsy. Epilepsy behav. 2018;88:373-379. Doi: 1 0. 1016/j. Yebeh. 2018. 09. 006. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131592180]
Summary: objective: anterior nucleus of thalamus (ant) deep brain stimulation (dbs) is becoming a more common treatment for drug-resistant epilepsy. Epilepsy and depression display a bidirectional association. Anterior nucleus of thalamus has connections to anterior cingulate cortex and orbitomedial prefrontal cortex, hence, a possible role in emotional and executive functions, and thus, ant dbs might exert psychiatric adverse effects. Our aim was to evaluate previous and current psychiatric symptoms in patients with epilepsy undergoing ant dbs surgery and assess the predictability of psychiatric adverse effects. Programming-related psychiatric adverse effects are also reported. Method: twenty-two patients with ant dbs for retractable epilepsy were examined, and a psychiatric evaluation of depressive and other psychiatric symptoms was performed with montgomery and? Sberg depression rating scale (madrs), beck depression inventory (bdi), and symptom checklist prior to surgery, concentrating on former and current psychiatric symptoms and medications. The follow-up visit was one year after surgery. Results: at the group level, no changes on mood were observed during ant dbs treatment. Two patients with former histories of depression experienced sudden depressive symptoms related to dbs programming settings; these were quickly alleviated after changing the stimulation parameters. In addition, two patients with no previous histories of psychosis gradually developed clear paranoid and anxiety symptoms that also relieved slowly after changing the programming settings. Conclusion: the majority of our ant dbs patients did not experience psychiatric adverse effects. Certain dbs parameters might pre dispose to sudden depressive or slowly manifesting paranoid symptoms that are reversible via programming changes. Reported events: patient 1: a (b)(6) year-old woman who received bilateral anterior nucleus of the thalamus (ant) deep brain stimulation (dbs) for refractory epilepsy was programmed with monopolar stimulation with active contacts 2/10 (voltage: 4/4 v, therapeutic current: 4/6. 6ma current, 90? S pulse width, and 140 hz frequency). After six months, her seizure frequency was halved. Unfortunately, after 10months of stimulation, the patient reported sleep disturbances and feeling depressive, and soon afterwards, she began to feel paranoid and annoyed. The change was insidious and happened without any clear triggering factors. Her initial psychiatric symptoms were mild but worsened gradually to an outright psychotic state including delusions and erotomanic thoughts. She also began to experience psychogenic nonepileptic seizures along with anxiety and low mood. Citalopram (cit) 20mg was provided to treat her depression and anxiety. The stimulation contacts were also changed tomore cranial, active contacts were moved to 3 and11, and the current was decreased to 5. 9 ma/ 6. 3ma (right/left). After this reprogramming, the patient felt better, and gradually, her psychotic symptoms disappeared. Citalopram was continued 40 mg/day, patient also had her ongoing aeds: zonisamide (zns) 400mg, pregabalin (pgb) 600 mg, and lacosamide (lcm) 400 mg, quetiapine 25 mg was administered in the evening for sleep disturbances, when necessary. Her seizure frequency improved further to three seizures/month (a 90% reduction compared with pre-dbs baseline). Her mood stabilized, and the psychotic symptoms had relieved when evaluated in the one-year follow-up. All patients were reportedly implanted with 3389 model leads. No other specific device information could be obtained from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-03723 |
| MDR Report Key | 8201547 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2018-12-27 |
| 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 | 2018-12-27 |
| 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. Other | 2018-12-27 |