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 Unspecified Infection (1930); Cognitive Changes (2551)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

De noordhout, a.M., mouchamps, m., remacle, j.M., delstanche, s., bonhomme, v.,& gonce, m.Subthalamic deep brain stimulation versus best medical treatment: a 12-year follow-up.Acta neurologica belgica, 122(1), 197¿202.2022.Doi: 10.1007/s13760-022-01874-8.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 of the date that the article was accepted for publication as the event dates and publication date 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_ins_stimulator, serial # unknown, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract/ summary: purpose - electrical stimulation of the sub-thalamic nucleus (stn-dbs) is well established to alleviate motor fluctuations in advanced parkinson¿s disease but little is known about its very long-term efficacy.Methods - we followed over 12 years 15 parkinsonian patients having undergone stn-dbs and compared them to a matched group of 14 patients with best medical drug therapy.All had been considered as good candidates for surgery.They were allocated to each group depending on their own decision.Results - after 12 years, mortality rates were similar in both groups.In the dbs group, best ¿on¿ updrs iii scores (on medications, on stimulation) remained significantly better and dyskinesia shorter and weaker than in the drug-treated group (on medication only).Yet, looking at independent life and quality of life (qol) evaluated with pdq39, no significant difference could be observed between groups at the end of follow-up, probably due to development of dopa- and stimulation resistant motor and non-motor symptoms like falls, freezing, dementia, apathy and depression, the latter two more frequent in the dbs group.Conclusion - drug- and dbs-resistant symptoms and signs occur more often after long disease evolution and in elder patients.It might be why differences in qol between both groups no longer existed after twelve years as, compared to other studies, our patients were older at inclusion.Reports/events: a patient showed infection of the battery after 3 months, displaced to another site (abdomen instead of pectoral region).Two patients (aged (b)(6)) had unsuccessful drowning suicide attempts in the first months after surgery.They had developed impulse control disorders soon after dbs, while no such problems were present before the surgery, despite both were under dopamine agonists.Brain ct indicated that active contacts of electrodes were correctly located inside the sub-thalamic nucleus (stn), though with less precision than with mri, not routinely used at that time.Yet, motor improvement in both argued against misplacement of leads.The following device information was identified in the article: lead models 3389.

• 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: 13677873
• MDR Text Key: 286677810
• Report Number: 2182207-2022-00378
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other
• Type of Report: Initial
• Report Date: 03/05/2022

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
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/07/2022
• 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; Other
• Patient Age: 63 YR
• Patient Sex: Male