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 Discomfort (2330); Irritability (2421); Cognitive Changes (2551); Confusion/ Disorientation (2553); Insufficient Information (4580)

Event Date 01/12/2022

Event Type  Injury  

Event Description

Horn ma, gulberti a, hidding u, et al.Comparison of shod and unshod gait in patients with parkinson's disease with subthalamic and nigral stimulation.Front hum neurosci.2021;15:751242.10.3389/fnhum.2021.751242.This single-center, randomized, double-blind, crossover clinical trial assessed shod and unshod gait in patients with pd with medication in different dbs conditions (i.E., stim off, stn dbs, and stn+sn dbs) during different gait tasks (i.E., normal gait, fast gait, and gait during dual task) and compared gait characteristics to healthy controls.Notably, 15 patients participated in the study, and 11 patients were analyzed after a dropout of four patients due to dbs-induced side effects.Reported events: 4 patients withdrew from the study due to side effects such as general uncomfortable feeling, increased confusion, hallucinations, a ggressiveness and a lack of beneficial effects of levodopa intake.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

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.

• 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: 13861838
• MDR Text Key: 287691452
• Report Number: 2182207-2022-00481
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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
• Date Manufacturer Received: 03/03/2022
• 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 Age: 63 YR
• Patient Sex: Male