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 09/13/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389, lot# unknown, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 3389, serial/lot #: unknown, age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority 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 of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Murilo martinez marinho *, lorena broseghini barcelos, michelle hyczy de siqueira tosin, carolina candeias da silva, vanderci borges, henrique ballalai ferraz, ricardo silva centeno.Effect of bilateral deep brain stimulation on the subthalamic nucleus on patients with parkinson¿s disease: an observational and non-blinded study.Doi 10.1016/j.Inat.2021.101380 objective: this study analyzed the influence of subthalamic nucleus deep brain stimulation (dbs) in motor parameters and patients¿ quality of life with parkinson¿s disease (pd) evaluated before and after 12 months of the surgical procedure.Methods: a cohort of 20 patients with pd who underwent dbs implantation in the subthalamic nucleus was included.Pre and on-dbs postoperative data in on and off-medication periods related to motor functions and quality of life, from the application of validated scales, were collected to verify possible relationships between changes in these parameters and the surgical procedure.Results: a significant decrease in the hoehn and yahr scale diseasestage and in the levodopa equivalent dose (p <(><<)> 0.001) was verified in the off-medication period when we compared baseline and post-12 months data.A significant decrease in dyskinesias (p = 0.009) was observed during the on-medication period by evaluating the udysrs scale.Concerning motor functions verified through the updrs-iii scale, it was obtained a significant reduction in total scores (p = 0.001), besides a decrease in rigidity scores for upper and lower limbs (p <(><<)> 0.05) during the on-medication period.During the off-medication period, scores of updrs-iii demonstrated a significant decrease, except for the ones related to speech and amplitude of resting tremor.Regarding the quality-of life assessment, scores obtained from pdq-39 showed that, after 12 months of electrode implantation, there was a significant decrease in mobility, daily living activity, and stigma parameters (p <(><<)> 0.05).Conclusions: results obtained allow us to conclude that dbs of the subthalamic nucleus in patients with pd improves motor function in both on and off-medication periods, improvement of the disease stage in the off-medication period, with no change in the on-medication period, also an improvement in the patient¿s self reported quality of life and a significant reduction in the dose of l-dopa.Reported events: it was reported that 2 patients experienced an infection and had their systems explanted.

• 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: 13091195
• MDR Text Key: 288323205
• Report Number: 2182207-2021-02235
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2021

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: 11/30/2021
• Initial Date FDA Received: 12/27/2021
• 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: 42 YR
• Patient Sex: Male