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

Model Number 97800

Device Problems Electromagnetic Interference (1194); Pocket Stimulation (1463)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Urinary Frequency (2275); Insufficient Information (4580)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is estimated; month and year are valid.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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that caller stated that the patient has frequent uti's and was in the hospital last week for an abdominal cat scan.Caller stated that since the cat scan, the patient's incontinence has returned and they have been having to change their pads nonstop.Caller added that they are wondering if the cat scan could have thrown the implant out of whack.Patient services reviewed compatibility considerations for a cat scan with the caller and offered to walk the caller through checking to see if the implanted system was on.Patient services walked the caller through connecting to the patient's settings.The therapy was on.Patient services reviewed stimulation considerations with the caller and the caller opted to increase the stimulation.The patient began to feel the stimulation only it wasn't in the bike-seat, it was at the ins site.Patient services reviewed with the caller that the patient should only be feeling the stimulation in the bike-seat and redirected the caller to follow up with the patient's health care provider (hcp) to check the implanted system but suggested the caller could try a different program to see if the patient could find a setting where they could feel the stimulation in the bike-seat.The caller stated they really would rather just follow up with the patient's hcp and a manufacturer representative could make an adjustment.Caller stated they've never really touched the patient's external equipment and that a rep would always change the patient's settings at the hcp office.The caller opted to turn the stimulation down a bit but patient felt something "sharp" in their "butt cheek" below the ins site but still not in the bike-seat.The caller opted to turn the stimulation down to a level where the patient didn't feel the stimulation any longer but was still slightly higher than where the patient initially started.They were going to monitor the patient's symptoms in the meantime.Caller stated they didn't know what could be causing the patient's current issue because a recent urine culture came back negative for uti but the patient was still constantly urinating since they were in the hospital last week and had the abdominal cat scan.Caller was going to follow up with the managing health care provider to check the implanted system and to schedule an appointment to meet with a manufacturer representative.Patient no longer sees their implanting hcp for follow up.They are now going to a hcp in tampa fl.Patient services transferred the caller to device registration to update the patient's record at call's end.Additional medical information was provided: caller mentioned the patient goes to see the doctor on a monthly basis because they have frequent utis.Patient lives in an assisted living facility.

• 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: 18731101
• MDR Text Key: 335705270
• Report Number: 3004209178-2024-05103
• 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
• Report Date: 02/19/2024

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 Expiration Date: 11/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/19/2024
• Date Device Manufactured: 06/03/2022
• 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: 83 YR
• Patient Sex: Female