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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Shaking/Tremors (2515); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was caller reported as far as a couple years ago, they noticed their voice was suffering, and they had seen their healthcare provider (hcp), however, the hcp was reluctant to make adjustments due to concern of throwing off other aspects of what their therapy was addressing such as their tremors in fear the tremors would get really bad where they wouldn't be talking at all, and the caller stated their voice was growing worse, but the reluctance came from that their tremors were pretty well addressed unless they get really upset.The caller added that within the last year, they had developed a head bob.The caller stated they had a heart surgery in december, and the surgeon informed the patient not during surgery, but sometime maybe in the patient's time in the icu with the hcp, that their ins had become displaced.The caller stated the ins had been put under the muscle by hcp, and now the ins was just under the skin and when the patient would lie down, the ins would proceed to float into their throat.The caller stated they did not know what was wrong, just that when they would use their left arm to do something that required weight or lifting, the area hurt, thus, they were concerned that the leads were being stretched or were out of place, and was under the impression they believed they would need a replacement or have the ins put back into the proper place.The caller stated that the hcp that was reluctant was the provider they had seen prior to moving, and they went to a different neurologist since moving, and they were never going to go back to that hcp, so they didn't currently have one and needed one to further address the issue or for any referrals.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40 lot# v253613 product type lead product id 3389s-40 lot# v 251538 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 19-jan-2012, udi#: (b)(4) ; product id: 3389s-40, serial/lot #: (b)(4), ubd: 17-dec-2011, udi#: (b)(4) 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 it was unknown what led to the implant and lead movement.An appointment was scheduled with a healthcare provider (hcp) to try and find resolution to the issue.

• 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: 16462121
• MDR Text Key: 310494725
• Report Number: 3004209178-2023-02836
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: 03/23/2023

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 Expiration Date: 02/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/23/2023
• Date Device Manufactured: 08/16/2019
• 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
• Treatment: "SEE H10...."
• Patient Sex: Female
• Patient Weight: 70 KG