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); Energy Output Problem (1431)

Patient Problems Incontinence (1928); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that they wanted to check if their ins has been "completely deactivated".Caller said their hcp wants them to turn ins off for "2 months" and then they will have an appointment with hcp to see if they need ins.Attempted to walk caller through how to check if ins was turned off.Caller stated they did not see "off" or "on" but instead saw "deactivate" or "activate".Asked caller if they had activated mri mode recently.Caller said they did not think so, but had procedures done on their knee in the past.Tried to have caller exit screen.Caller was saying they say "finalize session" and something asking for a password.Had caller exit screen.Walked caller through how to select the my therapy app.Walked caller through how to navigate the tutorial.Once through the tutorial caller said they still did not see "off" or "on" on the screen.Attempted to explain, had caller power off handset and communicator.When caller powered handset and communicator back on, the tutorial appeared again.Caller stated they needed to use the restroom.Caller was directed to call patient services back to continue getting assistance in turning therapy off.Redirected back to patient services to continue troubleshooting.On 2023-05-09, additional information was received from the patient.They reported that they did not accomplished their desired goal and thought that they would have 98% relief of symptoms but they were still having leaks and have been increasing.They have an appointment to have the device removed in (b)(6) 2022 but were not approved by insurance at the time and have another insurance now and plan to take it off on (b)(6) 2023.

• 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: 17021681
• MDR Text Key: 316143428
• Report Number: 3004209178-2023-07487
• 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: P970004
• 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: 05/30/2023

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: 07/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/30/2023
• Date Device Manufactured: 01/18/2021
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG