MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Nausea (1970); Anxiety (2328); Depression (2361); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3387, serial# unknown, product type: lead; product id: 3387, serial# unknown, product type: lead.Other relevant device(s) are: product id: 3387, serial/lot #: unknown, ubd: , udi#: ; product id: 3387, serial/lot #: unknown, ubd: , udi#:(b)(4).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.If information is provided in the future, a supplemental report will be issued.

Event Description

Takashi morishita, yuki sakai, hitoshi iida, saki yoshimura, atsushi ishii, shinsuke fujioka, saori c.Tanaka, and tooru inoue." neuroanatomical considerations for optimizing thalamic deep brain stimulation in tourette syndrome." doi:10.3171/2021.2.Jns204026.Objective deep brain stimulation (dbs) of the centromedian thalamic nucleus has been reportedly used to treat severe tourette syndrome, yielding promising outcomes.However, it remains unclear how dbs electrode position and stimulation parameters modulate the specific area and related networks.The authors aimed to evaluate the relationships between the anatomical location of stimulation fields and clinical responses, including therapeutic and side effects.Methods the authors collected data from 8 patients with tourette syndrome who were treated with dbs.The authors selected the active contact following threshold tests of acute side effects and gradually increased the stimulation intensity within the therapeutic window such that acute and chronic side effects could be avoided at each programming session.The patients were carefully interviewed, and stimulation-induced side effects were recorded.Clinical outcomes were evaluated using the yale global tic severity scale, the yale-brown obsessive-compulsive scale, and the hamilton depression rating scale.The dbs lead location was evaluated in the normalized brain space by using a 3d atlas.The volume of tissue activated was determined, and the associated normative connective analyses were performed to link the stimulation field with the therapeutic and side effects.Results the mean follow-up period was 10.9 ± 3.9 months.All clinical scales showed significant improvement.Wher eas the volume of tissue activated associated with therapeutic effects covers the centromedian and ventrolateral nuclei and showed an association with motor networks, those associated with paresthesia and dizziness were associated with stimulation of the ventralis caudalis and red nucleus, respectively.Depressed mood was associated with the spread of stimulation current to the mediodorsal nucleus and showed an association with limbic networks.Conclusions this study addresses the importance of accurate implantation of dbs electrodes for obtaining standardized clinical outcomes and suggests that meticulous programming with careful monitoring of clinical symptoms may improve outcomes.Reported events: it was reported that one patient experienced wound dehiscence of the scalp incision site and underwent a wound revision.They also underwent a left dbs lead revision due to insufficient phonic tic suppression despite the motor tic improvement.The tip of the misplaced dbs lead on the left was on the border between md and cm nuclei, and 3 contacts were positions in the md nucleus.Two ventral contacts and 2 dorsal contacts of the revised lead were successfully placed in the cm nucleus and vl nucleus.This patient also experienced an electric shock sensation in their head, paresthesia in their hand, face and back of neck, anxiety, nausea, and squeezing sensation of head due to stimulation.They also experienced depressed mood and suicidal ideation at later follow ups.  it was reported that one patient experienced wound dehiscence of the scalp incision site and underwent a wound revision.They also experienced dizziness and paresthesia in their hand due to stimulation.They also had depressed moods.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12725887
• MDR Text Key: 279254266
• Report Number: 2182207-2021-01900
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• 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