MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number NEU_INS_STIMULATOR

Device Problem Malposition of Device (2616)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Twitching (2172); Dysphasia (2195); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 06/25/2022

Event Type  Injury  

Event Description

Almudena sánchez-gómez, paola camargo, ana cámara, pedro roldán, jordi rumià, yaroslau compta, álvaro carbayo, maria josé martí, esteban muñoz, francesc valldeoriola.Utility of postoperative imaging software on dbs targeting in patients with movement disorders.World neurosurgery.Doi: 10.1016/j.Wneu.2022.06.132.Objective: to evaluate the accuracy of the suretune3 postoperative imaging software in determining the location of deep brain stimulation (dbs) electrode based on clinical outcomes and the adverse effects (aes) observed.Methods: twenty-six consecutive patients with parkinson¿s disease (pd, n=17), essential tremor (et, n=8) and dystonia (n=1) that underwent bilateral dbs surgery (52 electrodes) were included in this study.Pre-surgical assessments were performed in all patients prior to surgery, and at three and six months after surgery, using quality-of-life (qol) and clinical scales in each case.The suretune3 software was used to evaluate the anatomical positioning of the dbs electrodes.Results: following dbs surgery, motor and qol improvement was observed in all patients.Different aes were detected in 12 patients, in 10 of whom (83.3%) suretune3 related the symptoms to the positioning of an electrode.A clinical association was observed with suretune3 for 48/52 (92.3%) electrodes, whereas no association was found between the aes or clinical outcomes and the suretune3 reconstructions for 4/52 electrodes (7.7%) from four different patients.In two patients the contact chosen was modified based on the suretune3 data and in two cases, the software helped determine that second electrode replacement surgery was necessary.Conclusions: the anatomical position of electrodes analyzed with suretune3 software was strongly correlated with both the aes and clinical outcomes.Thus, suretune3 may be useful in clinical practice, and it could help improve stimulation parameters and influence decisions to undertake electrode replacement surgery.Reported events: it was reported that 2 patients did not develop any adverse events but presented insufficient improvement of their pd symptoms on the right side of their bodies.Sub-optimal electrode positioning was detected in the left stn.The electrode was displaced towards an antero-lateral position and the other the electrode was medial and anterior of its optimal location.A new mri confirmed the misplacement of the electrodes and both patients had electrode repositioning, which improved their pd symptoms.Their clinical response after was very good and there were no adverse events.  it was reported that 2 patients developed capsular symptoms (dysarthria and facial twitching) when the right stn was stimulated at central contacts.However, when the ventral contact was testing in one patient there were good results.Clinical outcome in pd7 was suboptimal despite stimulating ventral contacts to avoid capsular effects, and repositioning of the right electrode was proposed.In both patients the electrodes were not shown to be excessively lateral.  it was reported 2 patients transiently experienced blurred vision due to diplopia when the left stn was stimulated at low intensity via ventral contacts.In line with the clinical findings, suretune indicated a ventro-medial location of the electrode in the left stn in one patient, although the electrode was correctly positioned in the other patient.Indeed when more dorsal contacts were used, neither of those two patients reported any adverse events and they achieved a good clinical outcome.  it was reported that 2 patients experienced diplopia at all contacts when the current was increased in an attempt to increase to achieve an acceptable antiparkinsonian effect.The program showed a medial location of both electrodes, in line with clinical findings.The patient refused to undergo further surgery to relocate the dbs system.  it was reported that 2 patients experienced frontal disinhibition 7 to 10 days after stimulation was initiated, even though a significant improvement in their pd symptoms was observed.In both cases suretune3 showed the left electrode to be in a medial location within the stn, in line with the clinical findings.They switched to a more dorsal contact and the behavioral symptoms improved in both cases while maintaining good control of pd symptoms.

Manufacturer Narrative

Concomitant medical products: product id: 3389-40, lot# unknown, product type: lead.Product id: 3389-40, lot# unknown, product type: lead.Product id: 3389-40, lot# unknown, product type: lead.Product id: 3389-40, lot# unknown, product type: lead.Product id: 3389-40, lot# unknown, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4); product id: 3389-40, serial/lot #: (b)(4); product id: 3389-40, serial/lot #: (b)(4); product id: 3389-40, serial/lot #: (b)(4), udi#: (b)(4).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.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.

• 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: 15364349
• MDR Text Key: 299329927
• Report Number: 2182207-2022-01697
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/22/2022
• 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: 63 YR
• Patient Sex: Male