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 Nerve Damage (1979); Pain (1994); Urinary Frequency (2275)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary and bowel dysfunction and urge incontinence.It was reported that they had the surgery yesterday and did well, but before going home, the manufacturing representative (rep) had programmed it.They thought it was ok, but when they got home, it was painful when sitting down and trying to get up; they could hardly stand.Patient (pt) said they used their equipment, turned it off, and the pain went away.Pt said they were calling for assistance to turn therapy back on and increase to a comfortable setting.I worked with pt to synch, turn therapy back on, and increase it to the same setting they were on yesterday before it was turned off, and pt said it was not painful when they were sitting; they did not feel any sensation.They reviewed the stim sensation information and were redirected to their doctor.Pt said they have their follow-up appointment on march 25th.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.Pt called back from registered number and stated it had been too high; they decreased it and it's comfortable.Pt had further general interstim questions.I reviewed the information and offered to send a quick guide and symptom diary.I reopened the case to send email additional information was received from the patient on 2024-03-18.Reviewed the function of the communicator and the status of the colored lights.The patient said she is waiting for the medtronic representative to call her today.I had the device implanted last wednesday and had it at 0.8 on program 3.She hasn't noticed any changes since the surgery.She is the same as she was before surgery.The patient is still tender from the surgery.She is urinating more than before the surgery.Wednesday night, the medtronic representative had it at 0.9 and was in really bad pain from the stimulation, so she turned it off.She thinks she called medtronic on thursday and put it on 0.8 with a medtronic representative over the phone.Last night, the patient got up twice to go to the bathroom.The patient said the trial worked better; she only woke up once during the night.The patient is going to wait for a medtronic representative to call today to let her know if she can make an adjustment.The patient called back to report that they met with a medtronic representative (rep) over the phone last monday (2024-mar-18) and made a therapy adjustment because the therapy still wasn't helping their symptoms.The patient refused to provide the rep's name, but the rep used her or his pronouns and was made aware of the issue on march 18, 2024.The patient stated that since they made the change, the therapy still wasn't helping; in fact, it was worse.The patient stated they've had a little bit of pain down there from the stimulation.Patient services reviewed therapy expectations, programming considerations, and stimulation considerations with the patient.The patient was worried because they had the stimulation too high to start because of the way it was set at the hospital and was worried they could have nerve damage.The patient stated they went home after their procedure, and every time they went to get up, they had pain that was "so bad" in the nerve between their legs that they finally turned it off that night until they spoke with their health care provider (hcp).Patient services redirected the patient to follow up with their hcp about their concerns and reviewed with the patient to turn therapy down if they still had pain.Patient services also provided a clinical date for the interstim therapy at the patient's request.The patient was redirected to follow up with their health care provider (hcp) about their symptom concerns and potential programming considerations.The patient stated they would reach out to their hcp and also noted that the rep would be calling them.The patient was concerned medtronic would reach out to their hcp about the event.Patient services reviewed documenting and reporting requirements with the patient.The patient was hoping their hcp would not be contacted.Documented the reported event.Patient services did its best to answer the patient's questions and document the reported information.

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: 19097148
• MDR Text Key: 340033379
• Report Number: 3004209178-2024-09006
• 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: 04/12/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 12/11/2023
• 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): Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female