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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Twitching (2172)

Event Date 08/31/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction or sacral nerve stimulation.The reason for the call was that the patient reported that they were still confused about how to use their device.The patient stated that when they left the hospital, they had the device set at 0.2, and they were told to increase stimulation, and they can continue to increase as long as it doesn't hurt.Pt stated they have been doing this and noticed when they get up to 6.6 that stimulation is on their right side and they feel stimulation towards their vagina on the right, and they feel something going down their right leg and into their right foot and toes.Pt reported their toes twitching.The implant mentioned is in their left buttock.Pt stated when they went in for follow-up, "she didn't get it" and told pt to "try to get it up to a.6.".Pt reported they have therapy at.9 now and they feel stimulation all the time in their vagina and their right toes twitch on and off.Pt also reported they had an accident today.I reviewed the therapy/stimulation overview.Pt stated they have never been advised on programming changes by their healthcare provider.Reviewed roles and general program information.I redirected the patient to a healthcare provider to further discuss therapy.Pt wanted to try changing programs on the call.The agent reviewed how to change programs, and pt successfully changed programs on the call.Pt decreased stimulation and stated that his toes were no longer twitching, but he was no longer feeling any stimulation.Pt increased stimulation again, then stated they were "not sure" if they were feeling stimulation in their bicycle seat area.Pt stated they were "sitting on it" and tried standing up.Pt continued increasing stimulation, then reported again that their toes felt weird.Pt reported, "this is really confusing.I'm just really not happy about this.".I redirected the patient to a healthcare provider to discuss therapy.Pt continued increasing stimulation and stated their right toes would not lay still.Pt decreased stimulation again and then confirmed feeling normal stimulation in a bicycle seat area that was comfortable (pt confirmed no longer feeling in toes).Pt provided the event date as "right out of surgery" and stated they noticed their toes spasmed (the agent was unable to hear what else pt said at this point in the call).Pt will monitor now that therapy adjustments have been made.The agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient in october 2023.They reported that the cause of their feeling stimulation down their leg and not at all was not determined.They are on program 7 and set at 1.7, and they feel the stimulation in their toes or right foot.They are going to the doctor today ((b)(6) 2023).Additional information was received from the patient on november 13, 2023.They stated that the stimulation was too strong when the toes twitched.When stimulation is lowered, the effects don't work with the incontinence.The cause was not determined.The doctor stated that they were on their own to figure it out.The issue was not yet resolved.Additional information was received from the patient on 2024-02-19.They reported that they are seeing a message on their controller that says the system is operating at its maximum settings and therapy cannot be increased.The patient states they first noticed this about a week or two ago.The patient states that most of the time the stimulation gives them a twitching sensation on their right foot, but now that has stopped.See rtg0488030.The patient also mentioned they had some bad results this weekend and couldn't control their bowels.The patient states they've tried other programs, but they continue to see this message appear.The patient stated they are very active and were wondering if something could've happened to the lead.The patient stated that from the beginning, they could feel their implant moving around in the pocket site.The patient states their device migrates, and they have to sometimes readjust it when they sit down because it gets twisted up.The patient stated they informed their doctor of this at the beginning, but the doctor didn't think it was a concern.The patient states the device feels a little lower than it should, and when they sit down, they can feel it.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.

• Brand Name: INTERSTIM X
• 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: 18740671
• MDR Text Key: 336872019
• Report Number: 3004209178-2024-05245
• Device Sequence Number: 1
• Product Code: EZW
• 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: 02/20/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/20/2024
• Date Device Manufactured: 06/12/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG