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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Hematoma (1884); Incontinence (1928); Urinary Retention (2119); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 978b128; lot#: va2wcse; implanted: on (b)(6) 2024; product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot#: (b)(6), ubd: 03-oct-2025, udi#: (b)(4); b3: date is estimated; month and year are 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.

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinary/bowel dysfunction.It was reported that they got the device because of so many bladder infections and leakage and urgency.Patient said, after implant it was working to help their symptoms and was working when they had their follow-up appointment, but starting about 2 weeks ago it stopped working.This morning they got up and felt like they couldn't pee and they were leaking and when they felt where the wire is located in the middle of their back, it felt different than it used to.They used to feel the disc in the middle and the box on the left side, now they couldn't feel the disc in the middle but could still feel the box on the side.Patient was calling because they couldn't seem to get answers, they were looking for some help and answers.They had talked with the manufacturer representative (rep) on the phone who wasn't much help.Pt said they left after surgery at 0.3 and they have increased stimulation to where it was uncomfortable then turned it down, confirming comfortable sensation in their pelvic floor.During the call pt was successful to synch with their ins and confirm stimulation was on.Patient denied any falls or traumatic accidents, no medical tests or medical procedures.Patient services reviewed therapy optimization information, stimulation sensation information, control equipment general use and function and recommended keeping a symptom diary to track results.Patient reported they have an appointment on april 12th with their new urology doctor but did not know the name.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the healthcare provider (hcp).The cause was determined.The day of placement on (b)(6) 2024, initially post placement hematoma was formed over op site and evacuated.The issue was resolved.The patient did not experience urinary retention prior to the device and catheterization was not a standard of care prior to the device.The issue was resolved.

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.

• 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: 19071300
• MDR Text Key: 339776651
• Report Number: 3004209178-2024-08728
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: 04/09/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/09/2024
• Date Device Manufactured: 11/20/2023
• 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
• Treatment: "SEE H11."
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 65 KG