MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37601

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Dizziness (2194)

Event Date 01/01/2018

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The patient reported that 3-6 months after implant date (patient could not confirm year of event, but they said it was probably in 2018), they were getting more migraines and dizziness.The patient noted that their ins was turned on for the first time 3-6 months after implant date.The patient mentioned that they got migraines and dizziness prior to implant date, noting that they had migraines maybe once a week.Now, however, the patient said they get migraines 11 days a month.The patient said their doctor has them on every migraine treatment, noting that they have gotten shots and take medication for the migraines.The patient said the migraine medication used to be helpful before they got the dbs implanted.The patient alleged that the dbs somehow "stimulates" the migraines.The patient stated that they keep their ins turned on at all times, so they were uncertain if the migraines would stop if they turned the ins off.The patient said the migraines cause them to have perceptual difficulty, and every 6 months they get in a fender bender (i.E.,hitting the garbage can with their vehicle) because of that.The patient added that they were dopey and sleepy for a couple of years after implant date, noting that it took them 2 years to be able to think very well.The patient mentioned that they were in bed most of the time during those couple of years.The patient mentioned that every time the dbs got "turned up," their migraines and dizziness got worse.The patient said their doctor has the ins at a minimal amount of current because they thought the patient would be frozen with parkinsonian symptoms if they turned the ins off.The patient said the migraines and dizziness affect their lifestyle, and they said their doctor won't let them drive anymore if they continue to experience the dizziness.The patient also mentioned that their memory has declined in the last 10 years, which they think was from hitting their head on so many things.The patient did notindicate that the ins was the reason they were hitting their head on things.The patient mentioned that camptocormia is a symptom they experience that is part of dystonia, which results in them being "all bent over." the patient said they think the dbs therapy helped slightly with the camptocormia, but their doctor was never able to turn the ins "way up" due to the migraines and dizziness.The patient said that 9 months or so ago, they had an mri and their doctor told them that the dbs was not in the right place.The patient stated that they were told "it's off of where you need it to be.Both of them are kind of off." agent was unable to get clarification as to what the patient was referring to.The patient mentioned that their doctor told them the ins battery will die pretty soon, and that they would like the patient to check the ins every month.The patient confirmed the ins is still on.The patient's reason for calling was to get in contact with "some type of phd guy" who they heard about at a conference that they said will ensure the dbs gets put in the right place next time.Agent did not who the patient was referring to, and the patient does not think it was a manufacturer representative (re p).The patient was redirected to their healthcare provider (hcp) to further address the issue.The patient said their next appointment with hcp will be on (b)(6) 2023.

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

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 cause of the stimulation issues and it not being in the right place was it being put in the ¿wrong¿ place at insertion.The consumer mentioned they tried adjusting the current but it didn¿t resolve the issue as it stimulated their vestibular migraines.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 16133221
• MDR Text Key: 308353918
• Report Number: 3004209178-2023-00417
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2023
• Date Device Manufactured: 08/16/2017
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 70 KG