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 Hematoma (1884); Hemorrhage, Cerebral (1889); Unspecified Infection (1930); Paresis (1998)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Age.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Sex.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Date of event.Please note that this date is based off the date the article was accepted for publication as the actual event date was not provided.Information references the main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown.Product id: 3389, serial/lot #: unknown.The reported events were from the following literature article: tsai st, tseng gf, kuo cc, chen ty, chen sy.Sevoflurane and parkinson¿s disease.Anesthesiology 2020; xxx:00-00 doi: 10.1097/aln.0000000000003177.If information is provided in the future, a supplemental report will be issued.

Event Description

The following events were reported in literature (see for citation): abstract: general anesthetics-induced changes of electrical oscillations in the basal ganglia may render the identification of the stimulation targets difficult.The authors hypothesized that while sevoflurane anesthesia entrains coherent lower frequency oscillations, it does not affect the identification of the subthalamic nucleus and clinical outcome.A cohort of 19 patients with parkinson¿s disease with comparable disability underwent placement of electrodes under either sevoflurane general anesthesia (n=10) or local anesthesia (n=9).Microelectrode recordings during targeting were compared for neuronal spiking characteristics and oscillatory dynamics.Clinical outcomes were compared at 5-yr follow-up.Under sevoflurane anesthesia, subbeta frequency oscillations pre-dominated.In addition, distinct dorsolateral beta and ventromedial gamma oscillations were detected in the subthalamic nucleus solely in awake surgery.Firing properties of subthalamic neurons did not show significant difference between groups.Clinical outcomes with regard to improvement in motor and psychiatric symptoms and adverse effects were comparable for both groups.Tract numbers of microelectrode recording, active contact coordinates, and stimulation parameters were also equivalent.Sevoflurane general anesthesia decreased beta-frequency oscillations by inducing coherent lower frequency oscillations, comparable to the pattern seen in the scalp electroencephalogram.Nevertheless, sevoflurane-induced changes in electrical activity patterns did not reduce electrode placement accuracy and clinical effect.These observations suggest that microelectrode-guided deep brain stimulation under sevoflurane anesthesia is a feasible clinical option.Reported events: one patient with subthalamic nucleus (stn) deep brain stimulation(dbs) for parkinson¿s disease (pd) (implanted under general anesthesia) developed an intracerebral hematoma and presented with mild hemiparesis.One male patient with stn dbs for pd (implanted under general anesthesia) developed an infection at the electrodes.The patient recovered fully after explantation and antibiotic treatment.The patient underwent successful re-implantation.The following device specifics were provided in the article: lead model 3389.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9860516
• MDR Text Key: 196546767
• Report Number: 2182207-2020-00042
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 03/03/2020
• 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: 46 YR