MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC DEEP BRAIN STIMULATION ELECTRODE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number 3387S-40

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

Patient Problems Pain (1994); Dysphasia (2195); Swelling/ Edema (4577)

Event Date 05/15/2021

Event Type  Injury  

Event Description

We provide here sae report for the ide, closed-loop deep brain stimulation for refractory chronic pain using summit rc+s (#g190160).This report covers an adverse event that is definitely related to the protocol but not necessarily unexpected.The adverse event was submitted to the irb within 5 working days of pi notification of the event and discussed with the data safety monitoring board for the study as described below.Subject (b)(6) underwent successful seeg implantation and inpatient trial brain stimulation (as per protocol) on (b)(6) 2021 with significant success: she has transient total relief of her baseline persistent chronic axial pain in neck, low back pain, bilateral hip pain and shooting nerve pain in her legs with seeg stimulation of prefrontal cortical leads in white matter adjacent to the body of the left caudate.Four target brain regions were identified for permanent implant based on this trial period.There were no complications related to stage 0 trial period.As per protocol, the subject progressed to stage 1 and received bilateral implant of two medtronic rc+s system two months after stage 0 on (b)(6) 2021.Following post-op assessment by neurosurgeon dr.(b)(6) and neurologist / study investigator dr.(b)(6), the patient was speaking fluently immediately after surgery and for at least 8 hours, without any language difficulties.Postoperatively, the patient was admitted to the transitional care unit for neurological evaluation and monitoring following dbs surgery per protocol.Overnight on (b)(6) 2021 the patient had a brief moment (lasting minutes) of being nonverbal but was still able to follow complex commands, as noted by the neurosurgery resident.She did not have any other deficits and her neurological exam was otherwise intact.The patient was also receiving oral and iv pain medication to control surgical pain (iv dilaudid 3-5 mg in 12 hours, and usual oxycodone 10 mg q4h prn) and there was some concern that medication side effects may have been causing cognitive /language difficulties.The patient underwent a helical ct imaging of the brain without intravenous contrast on (b)(6) 2021 which demonstrated a small area of edema without clear hemorrhage (some difficulty interpreting in the context of electrode metal artifact on ct) with apparent "rounded hyper density and surrounding edema associated with the left prefrontal dbs lead terminating adjacent to the caudate." later that day, her speech had improved, though she was having difficulty with spontaneous speech initiation, although naming, following commands and verbal repetition were all intact.The location of the edema was seen just anterolateral to the frontal horn of the lateral ventricle, consistent with a clinical syndrome known as 'transcortical motor aphasia (tcma)' the neurosurgical team evaluated the patient on (b)(6), and she had expressed that she wanted to leave the hospital to rest and recover in her hotel room.On the day of discharge (b)(6) the patient was tolerating a regular diet, pain was controlled and patient was deemed stable for discharge.The patient was evaluated in her hotel room on (b)(6) 2021 by the research team and a neurologist (dr.(b)(6) following discharge from the hospital prior to traveling home from (b)(6) to her home in (b)(6).Dr.(b)(6) conducted a thorough neurological evaluation and noted intact verbal naming, comprehension, repetition, but continued difficulty initiating voluntary speech and impaired speech fluency consistent with tcma, with no noticeable improvement from the prior day.Neurosurgeon dr.(b)(6) evaluation indicated that the condition is consistent with peri-lead edema following dbs surgery and is expected to be transient.Dr.(b)(6) recommended course of treatment includes reassurance to the patient that the speech impairment is due to transient swelling around the dbs lead and is self-limited.Fda was also notified.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC DEEP BRAIN STIMULATION ELECTRODE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; minneapolis MN
• MDR Report Key: 11885392
• MDR Text Key: 253165029
• Report Number: MW5101551
• Device Sequence Number: 2
• Product Code: NHL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021
• 2 Devices were Involved in the Event: 1 2

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: 3387S-40
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR