MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-05-31 for IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[146767759]
Date of event. Please note that this date is based off the date of publication of the article as the actual event date was not provided. Other relevant device(s) are: product id: 3389, serial/lot #: unknown; product id: 3389, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown. The reported events were from the following literature article: wang y, grewal ss, middlebrooks eh, worrell ga, stead m, lundstrom bn, britton jw, wu m, van gompel jj. Targeting analysis of a novel parietal approach for deep brain stimulation of the anterior nucleus of the thalamus for epilepsy. Epilepsy research 153 (2019) 1-6 doi: 10. 1016/j. Eplepsyres. 2019. 03. 010. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146767760]
The following reported events were reported in literature article: 1. Patient 1: one (b)(6)-year-old male patient underwent bilateral anterior nucleus of the thalamus (ant) deep brain stimulation (dbs) for treatment of epilepsy. Nine months after implant, the patient experienced a battery site infection. This resulted in explant of the battery and lead extensions. The cause of the delayed infection was unknown, but the patient did have dental work one month prior to the infection. 2. Patient 4: one (b)(6)-year-old female patient underwent bilateral ant dbs for treatment of epilepsy. The patient experienced a fracture of the right-side lead 18 months after the implant surgery. The lead was subsequently replaced. 3. Patient 9: one (b)(6)-year-old male patient underwent bilateral ant dbs for treatment of epilepsy. The patient experienced transient left hemiparesis. After implant, the patient developed transient contralateral motor weakness lasting one week. This was attributed to a centromedian intra-laminar parafascicular complex (cmpf) lead that was placed through the motor cortex rather than related to the ant lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-01214 |
| MDR Report Key | 8660267 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-31 |
| 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 | IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MBX |
| Date Received | 2019-05-31 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| 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. Required No Informationntervention | 2019-05-31 |