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 Problem Unspecified Infection (1930)

Event Date 10/03/2022

Event Type  Injury  

Event Description

Gina watanabe, frances tiffany cava morden, fay gao, michon morita, michiko kimura bruno.Utilization and gender disparities of deep brain stimulation surgery amongst asian americans, native hawaiians, and other pacific islanders with parkinson¿s disease in hawai`i.Elsevier.Doi: 10.1016/j.Clineuro.2022.107466.Introduction: despite its efficacy in parkinson¿s disease (pd) management, deep brain stimulation (dbs) is underutilized in sociodem ographic minorities.Previous investigations of racial disparities in pd aggregated asian american (aa) and native hawaiian or other pacific islander (nhpi) populations into a single category; however, these groups have significant health differences.We sought to characterize the pd population in hawai`i and the use of dbs among aa subgroups and nhpi patients to elucidate potential sociodemographic and clinical disparities.Methods: retrospective chart review of pd patients who received dbs from 2002 to 2021 was conducted at the queen¿s medical center on oahu, hawai`i.Hawai`i pd admissions from 2016 to 2020 were collected from laulima data alliance database.We compared the characteristics of dbs patients, total pd admissions, and hawai`i census data.Alpha level of <(><<)> 0.05 determined statistical significance.We did a subgroup analysis of white, aa and nhpi subgroups within the patients who underwent dbs.Results: analysis included 4215 pd admissions and 74 dbs surgeries.Compared to census data, whites (or: 1.67; p <(><<)> 0.0001) and aa (or: 1.18; p <(><<)> 0.0001) were overrepresented in total pd admissions; whereas nhpi (or: 0.64; p <(> <<)> 0.0001) and blacks (or: 0.17; p <(><<)> 0.0001) were underrepresented.Overall, males received dbs more than females.All nhpi patients who received dbs were male, despite 37.65 % of total nhpi pd admissions being female (p = 0.0049).Most dbs patients were aa (45.95 %), followed by whites (43.24 %), and nhpi (10.81 %).Conclusions: nhpi and black pd patients were disproportionately underrepresented in the ha wai`i pd population.All nhpi receiving dbs were male.These racial and gender disparities must be explored in future studies to achieve health equity and improved quality of care in a culturally sensitive manner.Reported events: it was reported that 4 patients had experienced an infection within the first 6 months of their dbs surgery.It was reported that 6 patients had developed an infection in long term follow up after their dbs surgery.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

Manufacturer Narrative

Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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: 15974199
• MDR Text Key: 305416007
• Report Number: 2182207-2022-02326
• 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: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

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: 11/17/2022
• Initial Date FDA Received: 12/13/2022
• 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
• Patient Sex: Male