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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Frequency (2275); Distress (2329); Sleep Dysfunction (2517); Hematuria (2558); Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the pt said they are on medication and has not slept in a while.Pt's doctor put the bladder implant in them and some time later got "all beat" and now doctor acts like they don't want to help with their program thing, and pt does not know how to do it.Pt said the lady they are supposed to be talking to told pt to talk to their doctor about 2 months ago.Pt said the "thing" is hurting them in the bottom of their stomach and pt went to see their doctor today and instead of helping the pt, they called security.Pt said they've been going through things.Pt said they don't go against them when they are supposed to be helping.Pt said they "want it taken out!" doctor doesn't want to help them, and lied and said pt was not there.Pt said they promised the doctor had the pt, but they turned their back on them.Pt said doctor told them "all you have to do is reprogram it," and pt messed with it.Troubleshooting offered to help pt with turning stim off.Pt repeated they wanted it taken out.Agent offered physician listings verbally during the call.Redirected pt to their doctor.The pt's relevant medical history included pt said about 3 months ago they asked one of the nurses if it could affect their mind and the nurse told the patient it could affect their mind.Pt was upset stating that they should have told the pt that before the implant.Pt stated, prior to implant, they had been using a catheter and were doing fine, every once in a while they needed the pills but that was okay, then they put the implant in to "make money." pt said they are by themselves and can't walk and can't jump up fast to go to the bathroom 4-5 times a night.They have to jump up and wipe up and change their towel and every day they have to wash.Pt said "they turned their back on" the pt this morning.Pt said the e mergency room told them to see their doctor.Pt repeated they wanted it taken out.During the call, pt also provided information about being on a walker.Pt said they have been in a walker for 16 years and there's a reason they are on the walker but no one wants to admit they made a mistake.Pt said they are going against them instead of helping.Additional information was received from the patient.They reported that the reason they were in the er over the weekend is because they are peeing blood.Pt states this issue started last week.Pt states the doctor wouldn't help them the following day, on monday, when they were having an emergency.The patient was redirected to their healthcare provider to further address the medical issue.Patient said that wants to have the device removed however implant physician will not see the patient.Patient said that they have tried finding a new physician to remove system however said is just being directlyback to implanting physician.Patient said left leg is hurting, said has turned therapy off however said that didn't make a difference regarding the pain.Patient said that during the night, is just soaking twice and uses a pull up.Patient asked if could check with pcp for physician listings.On 2022-11-04 the patient called back to go over different physician listings, which a couple they had talked to said they wouldn't take the device out and to go back to the implanting doctor, which the patient doesn't want to do.Patient will go ask their primary care doctor of a doctor that could take out the device.Patient doesn't know how to program stimulator.They really want to go back to the catheter.Patient is handicap and can't walk.They live by themselves and don't have anyone to help them use the external devices to help them hold them.They wanted to know if it had anything to do with his pain.When they were giving him shots 15 years ago think one time they missed a nerve and now they wet themselves.About a month ago, a manufacturing representative met with the patient.They programmed the stimulator for the patient.Then next couple days got in same situation and they said to see their doctor.They went to the emergency room two weeks ago and they said the same thing go see their doctor.On 2022-11-09 the patient called in again and indicated that they spoke with another doctor who was also not willing to work with the patient.

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.

• Brand Name: INTERSTIM II
• 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: 15879684
• MDR Text Key: 304461702
• Report Number: 3004209178-2022-15635
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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
• Report Date: 01/30/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/30/2023
• Date Device Manufactured: 07/07/2021
• 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: Male
• Patient Weight: 61 KG