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

Model Number 97800

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problems Dehydration (1807); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Type  malfunction  

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 (ins) for urinary dysfunction/sacral nerve stim.It was reported that the patient said they are having some problems with their therapy.Patient said if they get constipated, it seems like that have a lot of problems including a lot of leakage and they urinate more.Patient said they aren't sure when they first noticed symptom return but said they've tried increasing stim on 2 different programs and still hasn't gotten therapy relief.Patient said on both program 1 and 2, they increased stim and got a sensation in their leg and started noticing problems with their hips and right leg.Patient said they increased stim to 7.0ma and it was kind of extreme, so they changed from program 2 to program 1.Patient said usually when they are increasing stim and "testing it", at one point when they feel like it goes too high, they decrease stim.Patient said they started feeling this sensation about 2 weeks ago.Patient said the day before yesterday, they could hardly walk and it was hurting down their legs and their hip.Patient said they haven't tried decreasing stim or turning stim off because they were feeling so bad.Patient said they thought they were noticing the pain in their hip and legs due to their age and because they have so many medical problems, but they aren't sure.Patient also said within the last 2weeks, they've noticed that their ins is not very pronounced and they can barely feel where it is underneath the skin.Patient said around the incision it feels smaller and the device itself feels smaller but said it feels like it might be an inch and a half big.Patient said they think the size has decreased in the last 2 weeks.Patient mentioned they went to a store where they used a magnetic wand the other day but confirmed they've had no falls, trauma or procedures.Reviewed general therapy guidance and unexpected stim/uncomfortable stim.Offered to help patient with any adjustments, but troubleshooting was unable to be performed as patient said they would not like to troubleshoot over the phone today.Patient also said that their urine used to be clear, but looks more yellow or orange at times.Patient said they tried drinking more water and they think there's certain foods that effect urine.Patient said they noticed last week, thursday or friday somewhere.Redirected to hcp to address issue and check internal components.Patient said they would like to call their urologist's office to get an appointment to review therapy and medical issues.

• 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: 16523031
• MDR Text Key: 311557032
• Report Number: 3004209178-2023-03314
• 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: 03/10/2023

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: 03/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/10/2023
• Date Device Manufactured: 10/11/2022
• 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 Sex: Female