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

Model Number NEU_INS_STIMULATOR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Seroma (2069); Impaired Healing (2378); Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical product: product id neu_ins_stimulator, lot#, serial#, unknown implanted:, explanted:.Product type implantable neurostimulator information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #:, unknown.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.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

Luciano furlanetti, asfand baig mirza, ahmed raslan, maria alexandra velicu, charlotte burford, melika akhbari, elaine german, romi saha, michael samuel and keyoumars ashkan.Factors influencing driving following dbs surgery in parkinson¿s disease: a single uk centre experience and review of the literature.Journal of clinical medicine.Doi: 10.3390/jcm12010166.Abstract: parkinson¿s disease (pd) is a complex neurodegenerative disorder, leading to impairment of various neurological faculties, including motor, planning, cognitivity, and executive functions.Motor and non-motor symptoms of the disease may intensify a patient¿s restrictions to performing usual tasks of daily living, including driving.Deep brain stimulation (dbs) associated with optimized clinical treatment has been shown to improve quality of life, motor, and non-motor symptoms in pd.In most countries, there are no specific guidelines concerning minimum safety requirements and the timing of return to driving following dbs, leaving to the medical staff of individual dbs centres the responsibility to draw recommendations individually regarding patients¿ ability to drive after surgery.The aim of this study was to evaluate factors that might influence the ability to drive following dbs in the management of pd.A total of 125 patients were included.Clinical, epidemiological, neuropsychological, and surgical factors were evaluated.The mean follow-up time was 129.9 months.Dbs improved motor and non-motor symptoms of pd.However, in general, patients were 2.8-fold less likely to drive in the postoperative period than prior to surgery.Among the pd characteristics, patients with the akinetic subtype presented a higher risk to lose their driving licence postoperatively.Furthermore, the presence of an abnormal postoperative neuropsychological evaluation was also associated with driving restriction following surgery.Our data indicate that restriction to drive following surgery seems to be multifactorial rather than a direct consequence of dbs itself.Our study sheds light on the urgent need for a standardised multidisciplinary postoperative evaluation to assess patients¿ ability to drive following dbs.Reported events: 1.It was reported that there were 8 patient's that experienced revisions of their hardware due to wound healing problems, seromas a nd/or infections.2.It was reported there were roughly 3 patients with hardware issues.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• 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: 16449067
• MDR Text Key: 310329476
• Report Number: 2182207-2023-00358
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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
• Date Manufacturer Received: 01/31/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male