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

Model Number 97800

Device Problem Data Problem (3196)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Paresthesia (4421); Insufficient Information (4580)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urina ry/bowel dysfunction.It was reported that probably a week or two ago, they started having a return of urgency, running like a maniac to the bathroom and mild bowel leakage.Patient stated the bowel leakage wasn't as bad as it was before the implant but it was annoying.The patient stated that they hadn't had any falls or traumas that led to the return of symptoms.Patient services asked the patient if they'd spoken to their managing health care provider about the issue and the patient stated they hadn't spoken to the healthcare provider about it yet but they had to get an mri coming up in (b)(6) and the hospital where they were getting it done required a representative there for the mri in order to do the scan so the patient stated they had just planned on asking the rep about their programming and symptom concerns when they see rep at the mri on (b)(6) 2024.Patient services reviewed device description/function, therapy expectations and programming and stimulation considerations with the patient and the patient was able to connect to their settings and increase their stimulation to a level where they felt it comfortably in their bike seat region.Patient commented when going to connect to their settings with their external devices that "this was not easy".Patient services did not ask any further questions about the comment as they were focused on the reason for call.Patient was on program 3 and stated they thought they had been on program 12 before when they made a change with a rep over the phone, not program 3.Patient services reviewed with the patient that the therapy settings wouldn't change on their own and redirected the patient to follow up with their health care provider (hcp) to check to see their programming history if the hcp kept it in their medical record.When discussing stimulation considerations with the patient, the patient stated in the past when they had a therapy change, they would feel the "pinging" (fluttering/tingling) of the stimulation sensation for about 30 minutes afterwards and then it would stop.The patient was going to monitor their symptoms now that a change had been made, make an additional adjustment or call back for assistance if needed and reach out to their healthcare provider for further concerns about their symptoms.Documented reported event.No further action was taken by patient services.

Manufacturer Narrative

B3.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.

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.

Event Description

Additional information was received from the patient.Patient called back and repeated having the same therapy issues with their bladder and bowels.Patient stated they can't go any higher on the program they are on with it being comfortable.Patient switched the program and the call and increased the stim to a comfortable level.Patient confirmed stim in bike seat area.Patient will monitor symptoms to see if they improve.

• 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: 19130201
• MDR Text Key: 340451459
• Report Number: 3004209178-2024-09275
• 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,Followup
• Report Date: 05/10/2024

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: 04/18/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/10/2024
• Date Device Manufactured: 10/17/2023
• 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 Age: 70 YR
• Patient Sex: Female