MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35300R

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

Patient Problems Wound Dehiscence (1154); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Muscular Rigidity (1968); Cognitive Changes (2551); Dementia (4405); Convulsion/Seizure (4406)

Event Date 11/18/2023

Event Type  Injury  

Event Description

Schmidt sl, chowdhury ah, mitchell kt, et al.At home adaptive dual target deep brain stimulation in parkinson disease with proportional control.Brain.2023:awad429.Doi:10.1093/brain/awad429 abstract continuous deep brain stimulation (cdbs) of the subthalamic nucleus (stn) or globus pallidus (gp) is an effective treatment for the motor symptoms of parkinson¿s disease (pd).The relative benefit of one region over the other is of great interest but cannot usually be compared in the same patient.Simultaneous dbs of both regions may synergistically increase the therapeutic benefit.Cdbs is limited by a lack of responsiveness to dynamic, fluctuating symptoms intrinsic to the disease.Adaptive dbs (adbs) adjusts stimulation in response to biomarkers to improve efficacy, side effects, and efficiency.We combined bilateral dbs of both stn and gp (dual target dbs) in a prospective within-participant, clinical trial in six pd patients (n=6, 55 to 65 years, two women).Dual target cdbs was tested for pd symptom control annually over 2 years, measured by motor rating scales, on time without dyskinesia, and medication reduction.Random amplitude experiments probed system dynamics to estimate parameters for adbs.We then implemented proportional-plus-integral (pi) adbs using a novel distributed (off-implant) architecture.In the home setting we collected tremor and dyskinesia scores as well as individualized beta and dbs amplitudes.Dual target cdbs reduced motor symptoms as measured by updrs to a greater degree than either region alone (p¿<(><<)>¿0.05, linear mixed model) in the cohort.The amplitude of beta oscillations in the stn correlated to the speed of hand grasp movements for five of six participants (p¿<(><<)>¿0.05, pearson correlation).Random amplitude experiments provided insight into temporal windowing to avoid stimulation artifacts and demonstrated a correlation between stn beta amplitude and dbs amplitude.Pi control of adbs reduced average power, while preserving unified parkinson¿s disease rating scale motor examination (updrs iii) scores in the clinic (p=0.28, wilcoxon signed rank), and tremor and dyskinesia scores during blinded testing at home (n =3, p>0.05, wilcoxon ranked sum).In the home setting, dbs power reductions were slight but significant.Dual target cdbs may offer an improvement in treatment of motor symptoms of pd over dbs of either the stn or gp alone.When combined with pi adbs, stimulation power may be reduced while preserving the increased benefit of dual target dbs.Reported events: 1.One patient had a small (<(><<)> 1 cm diameter) postoperative cortical hemorrhage at a lead entry point, discovered after the par ticipant experienced a generalized seizure 24 h postoperatively (with two prior negative ct postoperative scans showing no hemorrhage).The participant was placed on levetiracetam for three months without seizure recurrence or long-term sequelae.The surgical adverse event indicated the potential for increased risk with dual target dbs. however, these did not significantly affect patient outcome.2.One patient required revision to the lead extension (to longer extensions) due to tightness in the neck.Extension tightening can occur with any clinical dbs system. however, these did not significantly affect patient outcome 3.One patient had delayed (> 1 year) superficial scalp dehiscence which required surgical washout and antibiotics, but the hardware was successfully preserved. late wound dehiscence can occur with any clinical dbs system. however, these did not significantly affect patient outcome.  4.One patient's mean moca scores worsened from pre-operative 27.8 to 4 25 at 2 years meeting the criterion for dementia.The participant showed a significant decline in cognition and functional status beginning about 6 months after surgery, but it is unknown if this decline was due to the additional electrode implant versus the progression of underlying parkinson's disease.The following device specifics were provided: ins model b35300r see attached literature article.

Manufacturer Narrative

D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: ; product id: neu_unknown_lead, serial/lot #: unknown, ubd: , udi#: a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.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.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence will be sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Https://academic.Oup.Com/brain/advance-article-abstract/doi/10.1093/brai n/awad429/7490826?redirectedfrom=fulltext medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 18721935
• MDR Text Key: 335743126
• Report Number: 2182207-2024-00741
• 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
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B35300R
• Device Catalogue Number: B35300R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male