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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.Liebenow, b., williams, m., wilson, t., haq, iu., siddiqui, ms., laxton, aw., et al.(2022) intracranial approach for sub-second monitoring of neurotransmitters during dbs electrode implantation does not increase infection rate.Plos one 17(8): e0271348.Https://doi.Org/10.1371/ journal.Pone.0271348.The average age of the patients reported in the article could not be identified.The gender of the majority of the patients reported in the article could not be identified.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.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.

Event Description

Liebenow, b., williams, m., wilson, t., haq, iu., siddiqui, ms., laxton, aw., et al.(2022) intracranial approach for sub-second monitoring of neurotransmitters during dbs electrode implantation does not increase infection rate.Plos one 17(8): e0271348.Https://doi.Org/10.1371/ journal.Pone.0271348.Summary: introduction: currently, sub-second monitoring of neurotransmitter release in humans can only be performed during standard of care invasive procedures like dbs electrode implantation.The procedure requires acute insertion of a research probe and additional time in surgery, which may increase infection risk.We sought to determine the impact of our research procedure, particularly the extended time in surgery, on infection risk.Methods we screened 602 patients who had one or more procedure codes documented for dbs electrode implantation, generator placement, programming, or revision for any reason performed at wake forest baptist medical center between january 2011 through october 2020 using international classification of diseases (icd) codes for infection.During this period, 116 patients included an irb approved 30-minute research protocol, during the phase 1 dbs electrode implantation surgery, to monitor sub-second neurotransmitter release.We used fisher¿s exact test (fet) to determine if there was a significant change in the infection rate following dbs electrode implantation procedures that included, versus those that did not include, the neurotransmitter monitoring research protocol.Results: within 30-days following dbs electrode implantation, infection was observed in 1 (0.21%) out of 486 patients that did not participate in the research procedure and 2 (1.72%) of the 116 patients that did participate in the research procedure.Notably, all types of infection observed were typical of those expected for dbs electrode implantation.Conclusion: infection rates are not statistically different across research and non-research groups within 30-days following the research procedure (1.72% vs.0.21%; p = 0.0966, fet).Our results demonstrate that the research procedures used for sub-second monitoring of neurotransmitter release in humans can be performed without increasing the rate of infection.Reported events: 1.It was reported that one patient had an infection within 30 days of the deep brain stimulation (dbs) procedure.2.It was reported that two patients had an infection within 30 days of the deep brain stimulation (dbs) procedure.The infectious pathogens included: methicillin-resistant staphylococcus aureus (mrsa), methicillin-sensitive staphylococcus aureus (mssa), and serratia marcescens.

• 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: 15716043
• MDR Text Key: 302868198
• Report Number: 2182207-2022-02034
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

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?: 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
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 11/02/2022
• 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
• Patient Outcome(s): Other