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

Model Number 3058

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Pain (1994); Dysuria (2684)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim, gastrointestinal/pelvic floor.It was reported that they didn't know if the therapy was working correctly for their symptoms.The patient stated that when they turned the stimulation up, it would hurt and that when they would pee it would hurt and that they had the urge to go to the bathroom but they couldn't hold it and they were leaking urine before they could get to the bathroom.The patient stated the issue began months ago but confirmed it began in 2023 and that it started when they started having issues with their foot that required 4 surgeries.The patient stated the foot issue began in (b)(6) 2023 and the patient stated they weren't sure if symptom return began then or after one of their surgeries where it stopped helping their symptoms.The patient stated they'd called their managing health care provider (hcp) about the issue and that the hcp told them to call patient services.Patient ser vices reviewed therapy expectations, device description/function and stimulation and programming considerations with the patient and the patient was able to successfully connect to their settings.The therapy was on.The patient then switched to a new program and increased the stimulation to a level that was comfortable and where they felt the stimulation in their bike-seat region.The patient was now going to monitor their symptoms now that a change had been made, make an additional adjustment or call back for assistance if needed and reach out to their managing health care provider for further concerns about their symptoms.The patient also inquired how long they had with their current ins and patient services reviewed stimulation battery longevity with the patient and redirected the patient to follow up with their hcp for a battery calculation.The patient confirmed when they were looking at their settings that they did not see a low battery message.Documented reported event.No further action was taken by patient services.Patient's relevant medical history included the patient stated they'd had 4 surgeries this year on their foot and that one of the surgeries had been for a problem with their foot that had been infected all the way to the bone.The patient reported they couldn't get a full body scan of their foot because of their current implanted system's mri compatibility and that's why they ended up having to have so many surgeries.Patient services reviewed mri compatibility guidelines with the patient and redirected the patient to follow up with their health care provider (hcp) regarding an mri conditional compatible system when it came time to replace their internal battery.The patient also commented when discussing their ins battery that the buttock that the ins was implanted in was smaller than the other buttock.The patient was unable to clarify further what they meant by this comment, only that the side the ins was on was smaller than the other buttock.

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.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: 18004688
• MDR Text Key: 326510003
• Report Number: 3004209178-2023-18341
• 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: 10/25/2023

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: 07/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/25/2023
• Date Device Manufactured: 01/19/2017
• 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 Age: 67 YR
• Patient Sex: Female