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 Wound Dehiscence (1154); Erosion (1750); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of 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.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.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

Ribeiro, l., chan-seng, e., gil, v., sanrey, e., coubes, p., <(>&<)> poulen, g.(2022).Submammary implantation of internal pulse generators for deep brain stimulation: long-term follow-up of device acceptance and quality of life in women.World neurosurgery, 167, e1025¿e1031.Https://doi.Org/10.1016/j.Wneu.2022.08.126 abstract/summary: - background: a submammary approach to implanting pulse generators is innovative and has yielded good aesthetic results in the current literature.It was our aim to make a comparison of patient device acceptance, tolerance, and complications between submammary and  abdominal device locations in deep brain stimulation.- methods: twenty-five and 28 patients were included in the submammary and abdominal groups, respectively.Our primary criterion was patient acceptance that was calculated using total florida patient acceptance survey (fpas) scores in each group.Secondarily, tolerance was assessed in the submammary group by means of a specific questionnaire.- results: total fpas scores from the submammary group [total fpas: 77.1 versus 74.7, p [ 0.29] revealed no significant difference when compared with the abdominal group.The same similarities were observed regarding the 4 subscales: return to function [16.3 versus 15.8, p [ 0.53] , device-related distress [22.0 versus 21.3, p [ 0.31], body image concerns [9.2 versus 8.6, p [ 0.14], and positive appraisal [17.8 versus 17.4, p [ 0.58].Tolerance was reported as good by the majority of the women from the submammary group.There was no evidence of higher infection rates in the submammary implantation (smi) group.- conclusions: smi is a satisfactory alternative to other deep brain stimulation locations.Smi is a feasible option for any young woman who is eligible for deep brain stimulation.Reported events: 1.Two women required surgical revision due to externalization of cranial leads to the skin in the submammary implantation (smi) group.In the first instance, the skin incision had slightly come apart with no signs of infection.The dbs system was left in place, and she was treated with antibiotics for 2 weeks following surgical closure.She made a complete recovery with no infection. in the second patient, the skin incision also came apart and exposed the leads.Surgical revision was performed, and antibiotics were administered for 4 weeks.The same complication occurred 3 weeks later at the same site, necessitating aggressive surgical treatment and requiring antibiotic treatment for 4 further weeks.Two years later, the same complication occurred at the submammary site and in front of the right electrode leading to a complete removal of the dbs system.The two patients needed repositioning of the implantable neurostimulator (ins).One of them needed a transposition of the ins in the abdominal location.

• 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: 15815776
• MDR Text Key: 303831401
• Report Number: 2182207-2022-02152
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 10/18/2022
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female