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

Model Number 97800

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Unintended Collision (1429); Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Event date is not known.Please see b5 for approximate date range, if applicable.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/bowel dysfunction and urge incontinence.It was reported that the patient called and reported that they hated the external devices, that they were 'hostile' and not user friendly and that "it sucks." the patient stated their health care provider (hcp) agreed and so did the person who would check their device at the clinic who worked with the va.The patient stated they liked the 3037 programmer so much better and that it was so much easier to use than the current external devices.Patient services started to walk the patient through connecting to their settings and the external devices paired immediately and the patient was able to connect to see their settings.The therapy was on.The patient mentioned while they were discussing external devices that they noticed the communicator when it was plugged in before they called patient services, that it's orange light was going off and on and it finally stayed solid orange so they thought that meant it was fully charged and unplugged it.Patient services reviewed communicator basic function with the patient and the patient stated it was probably that they hadn't used it in forever and confirmed that with the communicator unplugged as it was currently, there was no battery light lit up so they would work with patient services to connect to their settings and focus on charging the communicator up to a green light later.Patient stated they used a wall adaptor that had two usb ports and that the cable they used was their own cable and it seemed fine.Patient services did not ask any more questions about the comments as they were focused on the reason for call.The patient stated that initially with the ins, there was no comfortable setting they could find so the medtronic representative changed the numbers from "1, 2, 3, 4" to ".1,.2,.3,.4.".The discomfort from the stimulation before they found a comfortable setting was really the only "problem" they had with the device.The patient stated they wanted to increase the stimulation to where they felt the stimulation and back off but then they received a 'maximum settings reached' message on the call and couldn't increase any higher on program 1.The patient went to switch to program 2 and received an 'operation has failed.An error has occurred' and the option to end session.The patient ended the session and connected to their settings again and patient switched programs to program 2 and increased and received a 'maximum settings has been reached' message again.Patient confirmed they'd had a hard fall "about a month ago." patient services redirected the patient to follow up with their health care provider (hcp) to check the implanted system.The patient switched to program 3 and still got a 'maximum setting has been reached' message.Patient stated they would follow up with their hcp to check the system since the fall.Patient requested to be transferred to device registration at call's end to request an id card and to update their hcp information.Patient services also provided the patient with healthcare it's number to call at their own convenience to address the date and time concern and warm transferred the patient to device registration.Patient also wanted to make a suggestion: they stated medtronic should update the communicator charging port to a usb-c port so patients only needed one cable instead of two.Documented reported event.No further action was taken by patient services.

Event Description

Patient called back and referenced patient letter.Patient reiterated previously reported information and stated that their managing health care provider (hcp) (the implanting hcp on record) had ordered an xray and it was determined that the "lead was messed up." patient stated even manufacturer representative (rep) agreed when they spoke with the rep a few days ago and another rep that the lead was "messed up".Patient did not know specific causes of things happening and wanted to analyze the system after it was removed because they were scheduled to have the "whole thing done again" next month.Patient stated the surgery was scheduled for on (b)(6) 2024.Patient services reviewed with the patient that the hcp could send back the system for analysis and patient stated they wanted the system to be analyzed once it was removed so they'd talk to their hcp.Patient stated they couldn't imagine a fall causing their lead to be misplaced (messed up).Patient stated they just fell from standing and hit their hands on the pavement when they went down.Patient stated the radiologist said the lead was kinked and that a lead "doesn't just kink from a simple fall unless you fell from an airplane." patient also mentioned they did chair yoga and stretching was involved but nothing too strenuous that could have "kinked the lead" patient stated this was their 4th system and never had any problems before this.Patient also continued to elaborate on why they hated the external devices.They said they were "cheaper" and not user friendly compared to the previous remote they had which was user friendly.Patient also denied seeing an orange going off and on the communicator when patient services asked the patient for the cause of the orange light on the communicator going off and on.Patient services wanted to note that the patient was reporting a lot of information and patient services was doing their best to document the reported information.Patient reported relevant medical information that they had diabetes and had burning in their legs from peripheral neuropathy where they used a cream.The patient stated they had heard about the scs system and that they had considered getting that system to help with the neuropathy but have since changed their mind due to the kinked ins lead.Patient stated they wanted to determine what happened to their current system first before they went through with any more implants being implanted.

Manufacturer Narrative

Continuation of d10: product id: neu_unknown, product id: tm90q0, lot#serial#: (b)(6), product type: accessory, product id: 978b128, lot#: va2q65b, product type: lead.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: 18805415
• MDR Text Key: 336989544
• Report Number: 3004209178-2024-05959
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Date Device Manufactured: 12/16/2022
• 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
• Treatment: "SEE H11."; SEE H11.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 92 KG