MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Break (1069); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Paresthesia (4421)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3389s-40, serial/lot #: va0gds4, ubd: 20-nov-2016, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 07-feb-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient had a syncopal episode (unknown origin) as they were washing dishes in the kitchen.They fell and hit the right side of their head on the countertop where the lead/extensions are.They also cute their right ear.It was indicated that the injury was unrelated to the deep brain stimulation (dbs) therapy.Since this time, the patient has felt "zingers" (strong paresthesia) in their left face, arm/hand, and left leg depending on the positioning of their head (turning to one side), arms (putting on their glasses/lifting hands above their head).Palpating on the area where they hit causes the biggest "zinger" sensation.The manufacturer representative (rep) believes there is an intermittent fracture on their current programming (mainly the right brain lead) and when the wire "realigns" based on positioning or palpating on it, they get the full energy of their setting, causing the paresthesia.Currently, the patient does not have any persistent parkinson's disease symptoms that are impacting their overall function.When they went to the emergency room (er), they did get a ct scan.It was suggested they call to see if a cd of the images could be delivered to the physician for review.With the patient's covid situation, this is not occurring until quarantine period is done.The physician will try and view the ct scans that were taken.The issue has not been resolved.

Manufacturer Narrative

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

Additional information was received from a manufacturer representative (rep) clarifying that the physician does not believe the syncopal episode was related to the dbs system or therapy.The patient's first appointment to be seen by their neurologist was on monday, (b)(6) 2020.The patient developed a fever that morning and had to cancel their appointment because of covid restrictions.They are rescheduling the appointment.The patient only feels "zingers" (paresthesia) when they touch the lead/extension connection behind their ear; no other time.The cause was not determined.No actions have been taken yet and the issue has not yet been resolved.

Manufacturer Narrative

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

Additional information was received from a manufacturer representative (rep) reporting the patient had covid, so this is the first time the physician saw the patient in person since reporting this potential issue.The patient is doing well overall with their parkinson's disease symptom control.Every once in a while, they get a "zinger" but it is not reproducible with specific movements in the clinic.There are no significant differences in electrode impedances noted even with the patient doing certain movements with their neck/head.The only reproducible action in getting "zingers" is if they palpate directly on the lead/extension connection.The physician told the patient to stop touching it, report if the "zingers" change in intensity/frequency and if the parkinson's disease symptom control changes, or any other concerns.They will monitor electrode impedances over time and inform the rep of any significant changes and will consult neurosurgery for further input.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10984003
• MDR Text Key: 220686427
• Report Number: 2182207-2020-01443
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 02/04/2021
• Supplement Dates FDA Received: 12/30/2020; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR