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

Model Number 97800

Device Problems Display or Visual Feedback Problem (1184); Pocket Stimulation (1463)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Itching Sensation (1943); Burning Sensation (2146)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator for urinary dysfunction/sacral nerve stim.It was reported that the patient stated they were not that savvy with the external devices and they weren't given much training but they were leaking a little since they were implanted and they wanted to connect to their settings to check the device status.The patient stated they were at 2.2 ma during their trial and they were told at the procedure by a health care provider that they would set the patient's settings at the same setting for the permanent implant so the patient was expecting to see they were at 2.2 ma when they connected.The patient was at.6 ma on program 3. the patient stated "that's probably why it's not working as well" for their symptoms because they had been at 2.2 ma for the trial and the trial had been successful for them.Reviewed the difference between the trial device settings and the implanted system settings.The patient wanted to increase the stimulation to 2.2 ma.Reviewed stimulation considerations with the patient and the patient went a little beyond 2.2 ma before they could feel stimulation.The patient stated that they felt the stimulation at their implant site which was on their "backside" on the right about 2-3 inches from the waistline. it felt warm/hot back there.Was unable to determine if the patient meant the incision site was warm from the surgery or if the patient was experiencing stimulation at the implant site and that it felt "hot" (and not tingling/throbbing or fluttering).The patient stated they didn't have soreness at the incision and it wasn't red or swollen.The patient did state the incision site was itchy but stated they were told they could expect that from the healing process.Explained stimulation sensation was expec ted in the bike seat and patient stated they never felt the stimulation in the bike seat region during their trial.Reviewed with the patient that it would be best to follow up with their managing health care provider about their symptom concerns and about where they felt the stimulation/hotness.The patient stated the implanting hcp for their ins was (b)(6) however the patient was switching insurance at the end of the year so they were going to see another hcp.Sent the patient physician listings at the patient's request and advised for the patient to reach out to a physician if they were concerned about their healing process or where they felt the stimulation.The patient was going to monitor their symptoms and follow up with an hcp.

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 was received from the patient.Patient called in for assistance using external devices.Reviewed how to connect w/ the ins.Patient was able to connect w/ the ins.Patient said they are still having accidents but think they are doing better than they were before they got the device.Patient said they don't have the urgency any more.Patient said after sitting for awhile when they stand up they have a little leakage.Patient said they don't have to go to the bathroom every 1/2 hour.Asked the patient if they are getting a 50% reduction in symptoms and the patient responded by saying they are "getting a reduction".Patient said they don't get up in the middle of the night, they just have an accident.Patient said they drink a lot of water.Patient said they used to be really thirsty but they have not been diagnosed w/ diabetes.

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 was received from the patient.They reported that the cause of the settings to be at.6 instead of 2.2 is because after their permanent implant, that is what the doctor set it at.The indicated that the issue has been resolved by putting the setting at 3.0.The patient indicated that they are not feeling stimulation at the pocket side.The issue has been resolved.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 16087594
• MDR Text Key: 307693257
• Report Number: 3004209178-2023-00048
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 03/17/2023
• Supplement Dates FDA Received: 02/01/2023; 04/07/2023
• Date Device Manufactured: 10/05/2022
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 91 KG