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

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Seroma (2069)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off the date that the article was accepted for publication 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.D10.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, product id: neu_unknown_lead, serial/lot #: unknown, udi#: ; product id: neu_unknown_lead, serial/lot #: unknown.Https://movementdisorders.Onlinelibrary.Wiley.Com/doi/full/10.1002/mdc3.13846 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.

Event Description

Yearley ag, chua m, horn a, cosgrove gr, rolston jd.Deep brain stimulation lead localization variability comparing intraoperative mri versus postoperative computed tomography.Operative neurosurgery.2023;doi:10.1227/ons.0000000000000849.Background and objectives: commercially available lead localization software for deep brain stimulation (dbs) often relies on postoperative computed tomography (ct) scans to define electrode positions.When cases are performed with intraoperative mri, another imaging set exists with which to perform these localizations.To compare dbs localization error between postoperative ct scans and intraoperative mri.Methods: a retrospective cohort of patients who underwent mri-guided placement of dbs electrodes using the clearpoint platform was identified.Using brainlab elements, postoperative ct scans were coregistered to intraoperative magnetic resonance images visualizing the clearpoint guidance sheaths and ceramic stylets.Dbs electrodes were identified in ct scans using brainlab¿s lead localization tool.Trajectory and vector errors were quantified between scans for each lead in each patient.Results: eighty patients with a total of 157 implanted dbs electrodes were included.We observed mean trajectory and vector errors of 0.78 ± 0.44 mm (range 0.1-2.0 mm) and 1.57 ± 0.79 mm (range 0.2-4.2 mm), respectively, between postoperative ct and intraoperative mri.There were 7 patients with ct scans collected at multiple time points.Trajectory error increased by 0.15 ± 0.42 mm (p =.31), and vector error increased by 0.22 ± 0.53 mm (p =.13) in the later scans.Across all scans, there was no significant association between trajectory (p =.053) or vector (p =.98) error and the date of ct acquisition.Dbs electrodes targeting the subthalamic nucleus had significantly greater trajectory errors (p =.02) than those targeting the globus pallidus pars internus nucleus.Conclusion: commercially available software produced largely concordant lead localizations when comparing intraoperative mris with postoperative ct scans, with trajectory errors on average < 1 mm.Ct scans tend to be more comparable with intraoperative mri in the immediate postoperative period, with increased time intervals associated with a greater magnitude of error between modalities.Reported events:  1.Two patients had small < 3 mm) subdural hematomas.  2.One patient had a minor postoperative epidural hematoma. .

Manufacturer Narrative

Https://journals.Lww.Com/onsonline/abstract/9900/deep_brain_stimulation_ lead_localization.843.Aspx 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.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id b3300542m lot# serial# unknown product type lead product id neu_ins_stimulator lot# serial# unknown product type implantable neurostimulator product id 3389 lot# serial# unknown product type lead.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.

Event Description

Additional information was received from the corresponding author reporting that only three patient had the manufacturer's devices.One patient (m, 116.1 kg) had epidural hematoma.Initial head ct showed small post-op epidural hematoma adjacent to lead entry sites that was deemed clinically insignificant by neuroradiology.It was unknown if the issue resolved as there was no follow-up imaging available.One patient (m, 81.6 kg) had lead migration.The steps taken and resolution was unknown.

• Brand Name: 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: 17825949
• MDR Text Key: 324373414
• Report Number: 2182207-2023-01927
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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: 10/16/2023
• 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 H10...."; SEE H10
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male