MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Seizures, Grand-Mal (2168); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); Confusion/ Disorientation (2553)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Diaz a, cajigas i, cordeiro jg, et al.Individualized anatomy-based targeting for vim-czi dbs in essential tremor.World neurosurg.2020.10.1016/j.Wneu.2020.04.240.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.Date of event: please note that this date is based off of the date that the article was accepted for publication as the publication date and event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Information references the main component of the system.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, udi#: asku.Product id: neu_ins_stimulator, serial/lot #: unknown, udi#: asku.Product id: 3387, serial/lot #: unknown, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: deep brain stimulation of the ventral intermediate nucleus (vim) or caudal zona incerta (czi) is effective for refractory essential tremor (et).To refine stereotactic planning for lead placement, the authors developed a unique individualized anatomy-based planning protocol that targets both the vim and the czi in patients with et.33 patients with et underwent vim-czi lead implantation with targeting based on the authors' protocol.Indirect targeting was adjusted based on anatomic landmarks as reference lines bisecting the red nuclei and ipsilateral subthalamus.Outcomes were evaluated through the follow-up of 31.1 +/- 18.4 months.Active contact coordinates were obtained from reconstructed electrodes in the montreal neurological institute space using the matlab lead-dbs toolbox.Mean tremor improvement was 79.7% +/- 22.4% and remained stable throughout the follow-up period.Active contacts at last postoperative visit had mean montreal neurological institute coordinates of 15.5 +/- 1.6 mm lateral to the intercommissural line, 15.3 +/- 1.8 mm posterior to the anterior commissure, and 1.4 +/- 2.9 mm below the intercommissural plane.No hemorrhagic complications were observed in the analyzed group.Reported events: one patient implanted with deep brain stimulation (dbs) for essential tremor (et) experienced tonic-clonic seizure in the immediate postoperative period.There were no permanent complications associated with the event.One patient implanted with dbs for et experienced infection at the implantable neurostimulator (ins) implant site.There were no permanent complications associated with the event.Two patients implanted with dbs for et experienced waning stimulation effect, which required right lead repositioning (replacement and revision).One patient experienced this effect at 3 months, and the other at 2 years after initial implant.A significant reduction in tremor control together with intolerable stimulation-induced side effects was seen.After revision, both patients had short lived improvements in stimulation dependent tremor control that waned within 2-3 months.The following device information was identified in the literature article: lead model 3387.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10203712
• MDR Text Key: 201226413
• Report Number: 2182207-2020-00428
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR