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

Model Number 97800

Device Problems Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Incontinence (1928); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Cognitive Changes (2551); Dysuria (2684); Insufficient Information (4580)

Event Date 08/12/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they were going to the doctor on thursday (b)(6) 2023 because they had gotten a medical massage on (b)(6) 2023 (patient confirmed no equipment was used, that it was just a hand massage for spasticity) and they told the doctor not to touch where the battery was but the doctor massaged part of their back and the ins went haywire.The patient stated the device felt like it was vibrating in their vaginal area as they were driving home.The patient stated they switched to another program, but they were having leakage and bowel accidents "and all that stuff" so switched to another program but they were "paranoid," so they called their hcp about it and made an appointment.The patient stated since they switched to the new program the therapy seemed like it was working for them again but they had questions about the therapy and their symptoms like how they wouldn't be able to urinate, so they'd have to self-cath "once in a blue moon" and they wanted to know if that was normal.The patient confirmed that retention and self-catheterization was what they had to do prior to getting the device/therapy and that they even used to do botox prior to implant.The patient stated they would ask their hcp about their symptoms, but their hcp just told them to call medtronic.Patient services reviewed the role of patient services with the patient as well as reviewed therapy expectations and programming/stimulation considerations and how various types of activities and massages had the potential to impact the function of the device/therapy.The patient stated they thought they were definitely getting a 50% or greater reduction in their symptoms and that when they went to adjust the stimulation, they'd feel it in their bike-seat region and it was comfortable but sometimes they would wake up and feel like their "brain was just not connecting" to the rest of their "body parts." the patient further explained that they would get up every morning and they would have a bowel movement but sometimes though they felt like they had to urinate, they weren't able to get anything come out, so they'd have to move around a bit to make the urine come out and then they'd be able to go to the bathroom.The patient stated they would go to their bathroom maybe 3 times before they went to work because it just didn't all happen at the same time.The patient stated they'd follow up with their hcp on thursday to check the implanted system and from now on at their medical massages, they wouldn't allow them to go above their kneecaps.Documented reported event.No further action was taken by patient services.

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.

• 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: 17769791
• MDR Text Key: 324080797
• Report Number: 3004209178-2023-16063
• 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: 09/18/2023

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: 07/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/18/2023
• Date Device Manufactured: 02/08/2022
• 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 Age: 45 YR
• Patient Sex: Female