MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number NEU_INS_STIMULATOR

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical product: product id: neu_ins_stimulator, lot# , serial#, unknown, product type: implantable neurostimulator.Information.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.Pt age: 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

Tarun prabhala, fernando figueroa, tessa harland, melisande n.Nabage, julie g.Pilitsis.The use of salvage procedures for wound complications in neuromodulation.World neurosurgery.Doi: 10.1016/j.Wneu.2022.12.071.Objective: wound complications are a prevalent concern for neuromodulation procedures.While removal of the device was recommended, attempts to salvage expensive hardware have become commonplace.We examine our management in wound issues to aid in providing guidance for these situations.- methods: we identified 40 patients over an 8-year period in a large neuromodulation practice, who under went washout or partial salvage of hardware.We exam ined the efficacy of washout and partial explants on the ability to salvage the implants.Covariates including age, sex, body mass index, smoking status, anticoagulation, and device type were considered.- results: there were 29 washouts and 10 partial hard ware removal cases.Washouts were successful in 15/29 cases (51.7%), partial hardware removal was successful in 2/10 cases (20%), and removal with replacement was not successful (0 of 1).Washouts tended to be more successful than partial removal procedures (p [ 0.08).In cases of successful washout, the average duration between infectious symptoms and washout was 7.27 2.19 days.None of the demographic variables were associated with increased likelihood of washout failure.- conclusions: our results demonstrate a higher rate of washout failure in those who underwent partial device removal and in the presence of purulence at the surgical site.Further investigation must be conducted to determine the instances in which hardware removal is indicated to prevent failure or removal due to infection.Identification of these parameters will optimize therapeutic benefit and long-term financial impact.Reported events: 1.It was reported that 1 patients underwent bilateral dbs implantation and underwent a underwent a washout surgical intervention for infection.They were identified to have frank pus upon surgery, as well as wound erosion/erythema present, and an infection.Staphylococcus, cutibacterium acnes and enterobacter were found from the cultures.Antibiotics were given to the patients to resolve the issue.2.It was reported that 1 patients underwent bilateral dbs implantation and underwent a procedure to partially remove hardware due to complications.They were identified to have frank pus upon surgery, as well as wound erosion/erythema present, and an infection.S taphylococcus, cutibacterium acnes and enterobacter were found from the cultures.Antibiotics were given to the patients to resolve the issue.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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 16403220
• MDR Text Key: 309874627
• Report Number: 2182207-2023-00307
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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: 01/19/2023
• 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: 66 YR
• Patient Sex: Female