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 Hemorrhage, Cerebral (1889); Unspecified Infection (1930)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.A.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 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.(b)(4).

Event Description

Bucurenciu i, staack am, gharabaghi a, steinhoff bj.High-frequency electrical stimulation of the anterior thalamic nuclei increases vigilance in epilepsy patients during relaxed and drowsy wakefulness.Epilepsia.2020.10.1111/epi.16514.Abstract: the objective of this study was to evaluate the clinical results of asleep vim dbs using indirect coordinates and real-time interventional magnetic resonance imaging guidance.Retrospective review of a prospectively collected database was performed to identify patients with essential tremor undergoing asleep vim dbs using interventional magnetic resonance imaging guidance.Stereotactic and clinical outcomes were abstracted and analyzed using descriptive statistics reported events: a 6 mm, asymptomatic left-sided cortical intraparenchymal hemorrhage occurred in 1 patient.2 patients developed superficial surgical site infections (1 cranial,1 infraclavicular), both resolving with short courses of oral antibiotics.

• 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: 10149174
• MDR Text Key: 200375256
• Report Number: 2182207-2020-00343
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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
• Date Manufacturer Received: 05/29/2020
• 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): Other; Required Intervention
• Patient Age: 70 YR