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

Model Number 3058

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problems Diarrhea (1811); Incontinence (1928); Constipation (3274); Fecal Incontinence (4571)

Event Type  Injury  

Event Description

Information was received from a patient regarding an implantable neurostimulator for the treatment of bowel issues.It was reported that the therapy doesn't seem to be working properly.The patient said that about a month ago they noticed a change and now has constipation.The patient has been increasing the setting every couple of days, but said that they are still constipated.The patient said she might have had some fecal incontinence initially around that time as well.When asked about no changes to diet, the patient said that she had recently started eating salads, vegetables, and fruits.The patient also said that they have been taking a medication to help with constipation, clear lax, which they have been taking for over a year or longer.The patient did see a managing physician and np in october and was told that they needed a new battery and that they were going to do that in april.The patient said it was scheduled for april 8th.Reviewed therapy information and general programming information.Due to constipation, the patient will decrease the setting or turn stimulation off for a period of time.Patient to monitor and track symptoms.Reviewed the option to switch programs if needed.

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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

Ing decreased last wednesday, but she still took clear lax, and that corrected the problem.The patient said that the next day she had a normal bowel movement and took fibercon that day.The patient said that the next day she took clear lax again, had raisin-bran cereal, and had bowel movements at 6 pm.The patient said he had some leaking a little bit on the (b)(6), he had a bowel movement and a lot of leaking afterwards all day and made a decreased amplitude down yesterday around 4 pm and again at 7 p.M., and the patient said he was fine all night.The patient said that this morning she had a normal bowel movement with a lot of leaking afterwards and turned the amplitude down again.The patient asked for direction.I reviewed general programming information for the device, reviewed the medtronic role, and can review device information; however, i redirected the patient to consult with the managing hcp for management of the patient's overall condition.When asked, the patient said that the constipation has improved and that there is an overall improvement of 50% or greater in bowel issues.The patient will review and continue to track symptoms, adjustments, and results.

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 back regarding making an adjustment.Patient stated they were seeing an icon on programmer indicating it did not synch with ins.Patient services had patient try readjusting attachment and try connecting without attachment.Patient was not able to connect to ins.Patient services reviewed possible eos.Patient mentioned they thought they had been scheduled for a battery replacement on monday (presumed (b)(6) 2024 but it is just a consult appointment.Patient services directed patient to follow up with healthcare provider (hcp) regarding possible eos.Patient called back on (b)(6) 2024 and said that they couldn't stop the symptoms, just kept on coming out.Patient said they had decreased the setting however that hadn't helped.Patient mentioned they just experienced a death in their family.Patient services reviewed therapy information and general programming guidance.With instruction patient increased the setting.Patient to track adjustments and monitor symptoms and adjust setting as needed.Patient services reviewed meaning of icons on therapy status page and based on what was described, reviewed that ins battery had not yet reached the level that is low.Patient called back on (b)(6) 2024 regarding bowel symptoms.Patient st ated they had increased stimulation as previously noted and that helped, but they were still having some leakage after eating and yesterday they had soft bowel movements.Patient services reviewed stimulation expectations with patient.Patient will increase stimulation to a comfortable level and monitor symptoms.Patient services redirect to hcp if issue persists.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.Patient said they were still having issues however they didn't have replacement surgery until (b)(6).Patient said took a laxative yesterday((b)(6) 2024) and was able to go today.Patient asked if it was okay to take a laxative and loperamide.Patient services redirected patient to contact managing physician for medical direction.

• 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: 18597524
• MDR Text Key: 334037681
• Report Number: 3004209178-2024-02562
• 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: P080025
• 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,Followup
• Report Date: 05/06/2024

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: 10/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/29/2024; 04/04/2024; 05/02/2024
• Supplement Dates FDA Received: 02/14/2024; 04/26/2024; 05/06/2024
• Date Device Manufactured: 04/23/2019
• 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