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

Model Number 97800

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and fecal incontinence.It was reported that they had been having a lot of problems.When they first got the device it worked real good.In the past 5 to 6 months they had been having issues.They were having pure diarrhea constantly the last three days.They could hardly walk and their legs were hurting real bad.They had to have help because they couldn't even walk in their own house.The machine didn't work anymore.They used to be able to bring it up a few notches and have severe twinges in the vagina real bad so they would take it back down.They didn't know if it was hitting a nerve that was causing the pain in their legs and lower spine.Patient couldn't walk straight or stand up straight.The nurse practitioner said it was a sciatic nerve and hadn't done any tests.Patient called their insurance company and they said they didn't need a referral to see a neurologist.Patient had quite a bit of hemorrhoids and they never had them before.The patient was redirected to their healthcare provider to further address the issue., patient called back on 2024-mar-27 regarding previously noted issues.Patient stated they had 12 bowel movements in the last two days.Patient said they were getting weaker.Patient said they spoke with "a manufacturer representative (rep) yesterday who helped make an adjustment.Patient stated it seemed to help at first but now it was not helping today.Patient said it felt like something was stuck up their rectum which they thought was hemorrhoids because blood was coming out.Patient said they were still having diarrhea.Patient services reviewed therapy adjustment.Patient will maintain stimulation and monitor symptoms.Patient to follow up with their doctor if issues persist.

Manufacturer Narrative

Date is estimated; year is valid.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.

• 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: 19144140
• MDR Text Key: 340605031
• Report Number: 3004209178-2024-09421
• 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: 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
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 04/19/2023
• 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): Disability
• Patient Age: 72 YR
• Patient Sex: Female