MAUDE Adverse Event Report: MEDTRONIC ACTIVA PC+S

Model Number 37604

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Edema (1820); Weakness (2145); Weakness (2145); Anxiety (2328); Anxiety (2328); Depression (2361); Depression (2361); Ambulation Difficulties (2544); Cognitive Changes (2551); Cognitive Changes (2551); Lethargy (2560); Lethargy (2560)

Event Date 11/07/2017

Event Type  Injury  

Event Description

On (b)(6), we implanted our second subject in our darpa-funded project, "cortical records to evaluate anxiety, depression and impulsivity in parkinson's disease patients".She is a (b)(6) year old with rigid/akinetic pd, and on/off updrs iii scores of 21 and 41.She had a moca of 26, bai of 34, and bdi of 12.We are reporting a serious adverse event, a prolonged hospitalization due to lethargy and drowsiness.The causes were likely multifactorial: on days 1-3, due to large intracranial air entrainment and days 4-6 were likely from peri-lead edema extending into the midbrain.The afternoon and evening following implantation of the dbs and cortical leads on (b)(6), the patient showed significant cognitive impairment and lethargy.Post-surgery ct showed significant pneumocephalus on the side of the cortical lead.The insertion of the ipg was delayed until the patient showed improvements two days after dbs surgery (b)(6).The night after the ipg placement, the patient had another decline with more drowsiness, and a possible transient left sided weakness by report of the on call resident, so she had an additional head ct, moved back to the icu, and i came in to see her urgently.This ct showed no hemorrhage or migration of electrodes , and her pneumocephalus was gone.However, there was edema in the upper midbrain just deep to the electrode tips, consistent with peri-lead edema.Neurologically she was drowsy and did not open eyes, but followed commands, had no motor weakness, and was oriented to person and place.By saturday (b)(6), the patient's level of alertness was improving, and by sunday (b)(6), the patient was fully alert and oriented., and eating normally - back to baseline apart from being deconditioned from 6 days in bed.She will work with nurses and pt on her ambulation and will likely be released on (b)(6).It is possible that study involvement contributed to the adverse events, since introduction of the cortical lead, which involved passing it around the frontal convexity to the oribitofrontal surface, likely entrained more intracranial air than otherwise would have occurred with dbs alone.The resulting brain shift also may have increased the invasiveness of the dbs insertions, as they required two microelectrode passes to confirm target placement (often, only one microelectrode pass is needed).In response to this event and past experience, we are planning some additional modifications to our surgical procedure: we will further modify the burr hole entry site for the cortical lead to make it closer to the orbitofrontal surface, to reduce brain shift/air entry that can be exacerbated by placement of a relatively stiff lead from an entry on the frontal convexity "around a corner" to the orbitofrontal surface.We will place brain leads prior to the cortical lead, so that if additional brain shift occurs from cortical lead placement, it will not affect accuracy or invasiveness of lead placement.For patients who are over 65, we will also strongly consider staging the sides, separating the two sides by at least a month to reduce the chance of prolonged recovery.We believe these changes will/ may reduce the risk for further adverse events.Dates of use: (b)(6) 2017.

Event Description

Add'l info received from reporter on (b)(6) 2018 for report mw5073438.Note: this service adverse event is separate but related to the (b)(6) 2017 sae - prolonged hospitalization with lethargy and confusion following surgery (prolonged by 6 days).There was no defect related to a device in this report - the devices were as being used in an off-label indication consistent with the fda approved protocol (b)(4).Participant #2 had a previous identified serious adverse event (prolonged hospitalization and confusion) in the immediate post-operative period.This was thought to relocate to pneumocephalus and midbrain edema.After discharge she had incontinence, flattening of effect, reduced anxiety, and cognitive impairment.Her pre-surgical moca (montreal cognitive assessment) score was 24, while her moca score showed variable declines in the months following surgery ((b)(6)).She and her husband were reporting ongoing cognitive difficulties and trouble doing finances and keeping track of medications, but over several months ther was sense that she was improving slightly over time.The incontinence resolved and she appeared to be tracking info better during conversations.In (b)(6), her moca was 26, indicating some relative improvement in cognition; however, during (b)(6) she and her husband continued to report functional difficulties and cognitive decline.Due to ongoing motor, cognitive and mood complaints that were persistent after six months (a typical time frame for improvement secondary to effects of bilateral stn (subthalamic nucleus) implantation, she had a three-day clinic visit ((b)(6)) with a neurologist, neuropsychologist and psychiatrist, neuropsychological testing showed moca of 25/30.She showed fluctuating attention similar to levels seen prior to surgery.She showed a fairy focal pattern of executive dysfunction.Her executive function at baseline was below expectations, but she performed more poorly on executive function tasks and their reports of her day-to-day function are also consistent with significant executive dysfunction (has a hard time holding info in mind, has difficulties completing questionaires, can't keep track of the bills anymore, couldn't organize her medications or remember to take them at the right time, is getting confused by anything requiring multiple steps.) interview with her son also confirmed day-to-day difficulties and the lack of relative improvements in her cognitive state eight months post surgery.In summary, participant #2 appears to have had a post-operative decline in executive function.It appears unlikely that there will be add'l major improvement in the future.We have discussed continuing to go down on her ropinirole dose and trying to add rivastigmine in order to try to maximize her cognitive abilities.There are multiple potential causes of this executive impairment.Cortical paddle placement in pfc.While there was no evidence of cortical confusion, there was brain shift induced by paddle placement, and perhaps continued pressure on the right posterior frontal lobe due to the stiffness of the paddle.Bilateral stn electrode placement.Individuals with relatively low moca scores and older age can show cognitive difficulties following bilateral surgery.This is often temporary and resolves over time.Progression of pd.

Event Description

On (b)(6), we implanted our second subject in our darpa-funded project, "cortical records to evaluate anxiety, depression and impulsivity in parkinson's disease patients".She is a (b)(6) year old with rigid/akinetic pd, and on/off updrs iii scores of 21 and 41.She had a moca of 26, bai of 34, and bdi of 12.We are reporting a serious adverse event, a prolonged hospitalization due to lethargy and drowsiness.The causes were likely multifactorial: on days 1-3, due to large intracranial air entrainment and days 4-6 were likely from peri-lead edema extending into the midbrain.The afternoon and evening following implantation of the dbs and cortical leads on (b)(6), the patient showed significant cognitive impairment and lethargy.Post-surgery ct showed significant pneumocephalus on the side of the cortical lead.The insertion of the ipg was delayed until the patient showed improvements two days after dbs surgery (b)(6).The night after the ipg placement, the patient had another decline with more drowsiness, and a possible transient left sided weakness by report of the on call resident, so she had an additional head ct, moved back to the icu, and i came in to see her urgently.This ct showed no hemorrhage or migration of electrodes , and her pneumocephalus was gone.However, there was edema in the upper midbrain just deep to the electrode tips, consistent with peri-lead edema.Neurologically she was drowsy and did not open eyes, but followed commands, had no motor weakness, and was oriented to person and place.By saturday (b)(6), the patient's level of alertness was improving, and by sunday (b)(6), the patient was fully alert and oriented., and eating normally - back to baseline apart from being deconditioned from 6 days in bed.She will work with nurses and pt on her ambulation and will likely be released on (b)(6).It is possible that study involvement contributed to the adverse events, since introduction of the cortical lead, which involved passing it around the frontal convexity to the oribitofrontal surface, likely entrained more intracranial air than otherwise would have occurred with dbs alone.The resulting brain shift also may have increased the invasiveness of the dbs insertions, as they required two microelectrode passes to confirm target placement (often, only one microelectrode pass is needed).In response to this event and past experience, we are planning some additional modifications to our surgical procedure: we will further modify the burr hole entry site for the cortical lead to make it closer to the orbitofrontal surface, to reduce brain shift/air entry that can be exacerbated by placement of a relatively stiff lead from an entry on the frontal convexity "around a corner" to the orbitofrontal surface.We will place brain leads prior to the cortical lead, so that if additional brain shift occurs from cortical lead placement, it will not affect accuracy or invasiveness of lead placement.For patients who are over 65, we will also strongly consider staging the sides, separating the two sides by at least a month to reduce the chance of prolonged recovery.We believe these changes will/ may reduce the risk for further adverse events.Dates of use: (b)(6) 2017.

• Brand Name: ACTIVA PC+S
• Type of Device: ACTIVA PC+S
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7048356
• MDR Text Key: 92833678
• Report Number: MW5073438
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

2 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 Expiration Date: 11/30/2019
• Device Model Number: 37604
• Device Catalogue Number: 376040000H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2018
• 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: 0
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 44