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); Unspecified Infection (1930)

Event Date 07/16/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.The main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.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

Morgane soler-rico, jean-baptiste peeters, vincent joris, maxime delavallée, thierry duprez, christian raftopoulos.Mri-guided dbs of stn under general anesthesia for parkinson¿s disease: results and microlesion effect analysis.Functional neurosurgery movement disorders.Doi: 10.1007/s00701-022-05302-x.Abstract background the efficacy of the subthalamic nucleus (stn) stimulation for parkinson¿s disease has been widely established.The microlesion effect (mle) due to deep brain stimulation (dbs) electrode implantation has been reputed to be a good predictor for long-term efficacy of the procedure but its analysis in asleep implantation is still unclear.We thus analyzed mle rate in our strategy of targeting the stn on mri under general anesthesia and its correlation with our long-term results.Method we retrospectively analyzed 32 consecutive parkinsonian patients implanted with a dbs targeting the stn bilaterally under general anesthesia between october 2013 and december 2020.Targeting was performed after head frame and localizer placement using a stereotactic peroperative robotic 3d fluoroscopy (artis zeego, siemens) fused with preoperative ct and mri data.We collected intraoperative data, postoperative occurrence of mle, modification of unified parkinson disease rating scale item iii (updrs iii) postoperatively and at subsequent visit, as well as reduction of medication.Results the mean operative time was 223 min.No permanent complication occurred.Mle was observed in 90.7%.The mean follow-up time was 17 months.The updrs iii for the off medication/on stimulation condition improved by 64.8% from baseline.The mean dose reduction of prolopa after the surgical procedure was 31.3%.Conclusions direct targeting of stn under general anesthesia based on preoperative ct and mri data fused with a preoperative 3d fluoroscopy is safe.It allows for a high rate of postoperative mle (90.7%) and results in prolonged clinical improvement.Reported events: 1.It was reported that a patient underwent bilateral stn implantation for parkinson's disease.They developed an ins infection at 2 and 5 years after the procedures, and had wound dehiscence at 4 months after the ins replacement.The complete dbs system was removed and they received antibiotic treatment.Re-implantation was performed 6 months later.2.It was reported that a patient underwent bilateral stn implantation for parkinson's disease.They developed an ins infection at 2 and 5 years after the procedures, but no more information was available.

• 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: 15801976
• MDR Text Key: 303702677
• Report Number: 2182207-2022-02145
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 10/17/2022
• 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 Sex: Male