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

Model Number 37601

Device Problems Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Insufficient Information (3190)

Patient Problems Dysphasia (2195); Malaise (2359); Depression (2361); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported they were having difficulties with their system now and were having a lot of side effects where the voltage was turned up so high to treat their tremor but it effects their ability to walk, function and talk so the therapy has never been optimal.Pt said they'd been struggling with the programming, pt said their clinician and neurologist just turn up the voltage and there's too many side effects.Pt said they were on a setting now with a lower frequency and they were not too happy because they were struggling because their quality of life wasn't good.Pt said they wanted to see if they could have the whole system, lead and implant changed out to see if this would help.Pt thinks percept/sense sight leads may help.Pt said their initial dbs surgery lasted lasted 11 hours just to put the leads in due to complications.The patient was redirected to their healthcare provider to further address the issue.

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 they experience side effects when the voltage was turned up too high.The patient was unable to tolerate the high voltage, and their neurologist kept increasing the voltage every time they had an appointment (because the patient "wanted more results").The patient added that their oral medications (carbidopa-levodopa and rytary extended release) were "bumping heads" with the dbs therapy.The patient said they were suffering quite a bit because they couldn't figure out what was going on, and it made them really sick because they couldn't function with the amount of "electricity" in their brain.The patient said it put them in a more or less depressed state because of how weird it was if they increased the voltage, and changes the way their thoughts process.The patient mentioned that there was an adjustment made with their oral medications.The patient said it has been 3-4 months since their last adjustment, noting that their neurologist and rep were "dragging feet." however, the patient mentioned they had four different settings and had "fine tuned" them now.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 15457731
• MDR Text Key: 306086388
• Report Number: 3004209178-2022-12140
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2023
• Date Device Manufactured: 03/02/2020
• 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: 55 YR
• Patient Sex: Male