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

Model Number 97800

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

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Insufficient Information (4580)

Event Type  Injury  

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

Information was received from a patient who was implanted with an implantable neurostimulator for urinary/bowel dysfunction, urge incontinence.It was reported that they have issues with their bladder not being strong enough to go to the restroom.The therapy is working slowly and patient has noticed an improvement.They wanted to know if the interstim could cause uti.Patient has had quite a few uti's lately and had maybe one prior to implant.Patient stated they have been taking calcium for bone density issues as well as liquid iv and wondered if maybe the calcium was gathering into little rocks inside their urethra/bladder.Patient said whenever they have a uti they turn interstim therapy off while they are on antibiotics.Patient said they were given the interstim for urinary retention because their bladder walls were thick.Patient had a rezum surgery and it was real tender in there and they had pockets and inserting a catheter got stuck in the pockets a few times.Patient also stated one time they re-used a catheter and wondered if that introduce bacteria.Patient has been turning the therapy off about 2 days a month because they were told that would help let everything relax and start functioning on its own somewhat.Patient reported they do get up in the middle of the night when the therapy is off but they do sleep better when it is on.Patient's bladder is not getting larger and nowwhen they first wake up they can eliminate up to 700 ml but during the day it is only 3 to 500 ml.If they do occasionally have to go quite a bit during the day but they are only using the catheter 3 times a day now.When they first got the interstim they couldn't urinate in the ocean because of the waves and couldn't relax enough but now they are able to relax enough to urinate in the water which patient was happy about.Patient also mentioned they had changed programs and noticed their toes felt funny, however at their age they are maybe getting hammer toe which doesnt help.Ps reviewed expectations regarding program use and risks of overstimulation.Recommended patient turn therapy down or off if they ever suspect overstimulation.The patient was redirected to their healthcare provider to further address the issue.

• 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: 18739520
• MDR Text Key: 335761604
• Report Number: 3004209178-2024-05226
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/20/2024
• Date Device Manufactured: 07/26/2022
• 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