MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Headache (1880); Pain (1994); Transient Ischemic Attack (2109); Dysphasia (2195); Discomfort (2330); Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Type  Death  

Event Description

It was reported that patient rep stated patient passed away.Patient services (pss) asked if dbs was related to the death.Caller stated "well it could have been because the death certificate says cervical cardiovascular disease.Patient started having a ton of transient ischemic attack (tia)s and the neurologist said patient has probably had hundreds of tias due to" deterioration of the implant" and then said caller states "deterioration of blood vessels".Caller stated patient had essential tremor and not parkinsons.Caller stated not blaming medtronic, patient got 11 good years out of it. caller stated patient had not seen a neurologist for about 2 years.Patient was on hospice for about 6 months, off for a year, then back on in may or june before patient died.

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.

Manufacturer Narrative

Section d10 references: product id 3387s-40 lot# v641090 product type lead.Product id 3387s-40 lot# v754190 product type lead.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 received from the consumer reported the death certificate indicated ¿cerebral vascular disease¿ and that the dbs neurologist indicated the patient has likely had hundreds of tias which the healthcare provider thought was due to deterioration of blood vessels from the implants, specifically the ¿wires and stuff did it.¿ it was confirmed the implant was working as intended.

Event Description

Additional information received from the healthcare provider (hcp) the patient was seen on (b)(6) 2019 (high blood pressure noted at time of visit) where they mentioned in the last 9 months their balance had gotten worse and they were falling backwards (almost once a month).Their tremor was stable and they were happy with dbs therapy minus a slight change in their voice, difficulty swallowing, gait abnormalities and slight difficulty finding words.Slight adjustments were made in clinic to see if this could be improved, but resulting in an increase in symptoms so settings were reverted to initial.Two weeks prior they had an episode of possible tia, but the ct scan didn¿t show any event, so an mri was going to be ordered.At the next visit on (b)(6) 2020 the patient had headaches that were primarily on the left side of the face, jaw, and forehead.There was a point of tenderness along the zygoma just in front of their ear.The patient was worked up for temporal arteritis by their primary care physician and was placed on low-dose prednisone without much benefit.The patient was then seen by their dentist who felt it may be a tooth problem who extracted molars without relief.The patient was placed on a low dose of lyrica, but this didn¿t¿ seem to help either.In addition, they were completing a second course of antibiotics from the primary care physician and one form the dentist, but it hasn¿t made much of a difference either.During the appointment the patient was awake, alert and oriented and their speech was clear but somewhat tremulous and halting as they were having pain to the v1, v2, and v3 distributions of the trigeminal nerve.They also had scalp tenderness along the trunk of the superficial temporal artery with radiation upwards which made be related to the tenderness of the vasculature in the region.The patient had labs and a ct performed which showed no acute bleeds or midline shift or mass affects or herniations.The dbs electrodes were seen to extend into the basal ganglia/thalamus with no evidence for significant pseudomeningocele formation or abnormal fluid collections.On (b)(6) 2021, the patient was seen again and continued to have episodic tremors most often when accompanied by anxiety.In addition, they had some trouble eating with utensils and trouble walking.The patient was also diagnosed with dementia and the start of sundowning.At this time there was no evidence for tia¿s or stroke and appeared to have stable dbs programming with impedance values within normal range.

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18800812
• MDR Text Key: 336473447
• Report Number: 3004209178-2024-05938
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 10/31/2019
• 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): Death
• Patient Sex: Female