MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastr ointestinal/pelvic floor.It was reported that since implant, they would still have "breakthroughs" with the therapy and would normally "boot this thing up" every 3-4 months because they usually didn't have an issue with it.The patient reported that also since im plant, they would usually get "this sharp poking feeling" from the stimulation every now and again which was a sign to them that the therapy was working because they knew when they felt it, that they needed to get to the restroom right away, however they stopped feeling that sensation about 2 weeks ago.The patient stated they went to connect yesterday (2023-apr-16) and received the message "therapy may have stopped.Contact clinician." walked the patient through troubleshooting with their communicator and the patient received the same message.Had the patient restart the application and power off and back on the communicator and try to connect again however the patient received the same message.The patient stated they started a new regimen of pills recently that they thought was really helping their symptoms so they didn't notice an issue with their symptoms returning like theymight have experienced if they hadn't been on the regimen.The troubleshooting steps that were taken on the call did not resolve the reported issue.The patient was redirected back to their managing health care provider (hcp) to check the implanted system.Sent the patient physician listings at the patient's request.The patient was going to locate a new hcp and follow up with them to check the implanted system.Additional information was received from the patient.The cause oft eh sharp, poking feeling from the stimulation was unknown.They wrote that they had not been seen by the doctor to determine why the device had stopped functioning.The cause of not feeling stimulation was not determined.They stated they had not seen their doctor for the malfunction but they were scheduled to see them on may 30th.When asked what steps were taken to resolve the issue, they reported they wrote that they will see the doctor and a manufacturer representative (rep) for why the device failed.The issue was not yet resolved.The cause of the therapy may have stopped message was not determined and the issue was not yet 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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 17153605
• MDR Text Key: 318101720
• Report Number: 3004209178-2023-11219
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• 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
• Report Date: 06/19/2023

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: 06/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/19/2023
• Date Device Manufactured: 01/09/2019
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 73 KG