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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Migration or Expulsion of Device (1395); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  Injury  

Event Description

Lopez d.T., manzano g.E., medina a., prieto m.J., abud j.P., salazar l., vargas m.F., torres n., sacchettoni s.A.Long-term follow-up of parkinsonian patients operated on with deep brain electromodulation without intraoperative microrecording surgical neurology international 2023 doi: 10.25259/sni_673_2023.Abstract: background: deep brain electromodulation (dbem), also known as deep brain stimulation in different intracerebral targets, is the most widely used surgical treatment due to its effects in reducing motor symptoms of parkinson¿s disease.The intracerebral microelectrode recording has been considered for decades as a necessary tool for the success of parkinson¿s surgery.However, some publications give more importance to intracerebral stimulation as a better predictive test.Since 2002, we initiated a technique of brain implant of electrodes without micro recording and based solely on image-guided stereotaxis followed by intraoperative macrostimulation.In this work, we analyze our long-term results, taking into account motor skills and quality of life (ql) before and after surgery, and we also establish the patient¿s time of clinical improvement.Methods: this is a descriptive clinical study in which the motor state of the patients was evaluated with the unified parkinson¿s disease scale (updrs) and the ql using the parkinson¿s disease ql questionnaire 39 questionnaires before surgery, in the ¿on¿ state of the medication; and after surgery, under active stimulation and in the ¿on¿ state.Results: twenty-four patients with ages ranging from 37 to 78  years undergoing surgery dbem on the subthalamic nucleus were studied.An improvement of 41.4% in motor skills and 41.7% in ql was obtained.  conclusion: when microrecording is not available, the results that can be obtained, based on preoperative imaging and clinical intraoperative findings, are optimal and beneficial for patients.Reported events: 1) one patient had an infection beneath one of the burr-hole covers.When re-operated on, the pus was extending deeper, so the entire side was removed.After 3 months under antibiotics, a new lead was repositioned.The patient is recovering from their previous improvement.2) one patient had a rupture of the intra-cerebral portion of one lead.Another lead was changed.3) one patient had an upward displacement of the lead, probably due to not having been properly secured with the burr hole cover.The lead was replaced and properly secured.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id neu_unknown_ext (serial: unknown); product type: 0191-extension; brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; brand name neuromodulation device; product id neu_unknown (serial: unknown); product type: 0217-unknown; g2: citation: authors: lopez d.T., manzano g.E., medina a., prieto m.J., abud j.P., salazar l., vargas m.F., torres n., sacchettoni s.A.Long-term follow-up of parkinsonian patients operated on with deep brain electromodulation without intraoperative microrecording.Surgical neurology international 2023.Doi: 10.25259/sni_673_2023 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 [or 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 has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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: 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: 18646973
• MDR Text Key: 334616127
• Report Number: 2182207-2024-00424
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• 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 H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male