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)

Patient Problems Incontinence (1928); Pain (1994); Urinary Frequency (2275); Distress (2329)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinar y/bowel disfunction.It was reported that the patient said that they went to the doctor yesterday because they were still going to the bathroom frequently since implant and have also been experiencing some leaking.Patient said they were going to the bathroom 3 times an hour.Patient's hcp told them to increase stim until they could feel it and then decrease but patient had increased their stimulation on all of their programs up to a really high amplitude and they never felt anything.Patient decreased their stimulation and left it on program 7 because they got "fed up with it" (trying to increase stim to feel stim).Patient noticed they were still going to the bathroom on their own, not wearing pads and are able to make it to the bathroom but weren't sure if the ins was working.Reviewed stim sensation vs therapy relief and monitoring symptoms and patient confirmed understanding.At the end of the call, patient confirmed after making a change today that they have gone a longer time in between bathroom breaks and said they guess the ins is working.Patient will monitor symptoms.Additional information was received from the patient on (b)(6) 2023.They reported that their problem is after they talked to the manufacturer, they were told they may not feel the stimulation "the bubbling and the little pain that goes with it, with the bubbling".Agent reviewed stimulation expectations.Pt stated they have not felt stimulation and their hcp just told pt to increase stimulation until uncomfortable then turn it back down "two notches".Pt stated they kept increasing to "6, then i went up to 10" and they think they tried all 7 programs and they got nothing.Pt stated that is when they called and were told it is ok to not feel stimulation as long as it is working.Pt reported then the next day they had to go to the er and the er thought they were having a kidney stone and pt thought they were having a problem with the stimulator.Pt stated they did a cat scan and determined there was no irritation or any "inflammatory" or anything around the kidney so the er told pt they pulled a muscle.Pt stated before they went to er they "turned it all the way back down".Pt reported it was getting worse over the last couple days and they kept turning it up so they thought that was the problem.Pt stated since they were told they pulled a muscle they were sent home with a pain patch, pain medicine, and a muscle relaxer.Pt stated it was starting to feel better then reported the other day/yesterday pt was having a little bit of a problem with going more often.Pt stated dr advised pt increase stim to help with this.Pt reported they increased a little bit yesterday and reported the pain came back.Pt stated they thought this is related to this issue.Pt stated they have no sensation of "the bubbly thing i used to have".Redirected pt to their managing healthcare provider to discuss.Pt stated "it's very uncomfortable if you turn it up too high when i had the bubble thing going on, it was painful".Reviewed stimulation/therapy expectations.Pt reported pain is in their kidney area and the pain has been so bad to where they could not move.Pt provided event date as "the first time was probably the day after i called you" ((b)(6)).Pt later clarified they went to the er on the 16th and it started about around then.The patient was redirected to their health care provider to further address the issue.Additional information was received from the patient on (b)(6) 2023.They reported that they continue to leak and experience pain near the kidneys.They noticed that the ins is not flush with their buttock unless they push it in and moves "rolls" around very easily under the skin.Recommended patient follow up with managing physician to address symptoms.

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: 18155806
• MDR Text Key: 329779887
• Report Number: 3004209178-2023-21984
• 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
• Report Date: 11/16/2023

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/16/2023
• Date Device Manufactured: 03/23/2023
• 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: 55 YR
• Patient Sex: Female