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

Model Number 97800

Device Problem Pocket Stimulation (1463)

Patient Problems Undesired Nerve Stimulation (1980); Scar Tissue (2060)

Event Date 12/27/2023

Event Type  malfunction  

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 the caller (the patient's friend,) reported that since the patient got the implant, the therapy hadn't been working very well for the patient and that the therapy during the trial had worked much better for the patient.It wasn't working as well as they thought it would and the patient was not getting a 50% or greater relief in their symptoms since they were implanted.They also stated they needed assistance with using the external devices to connect to see the patient's settings.Patient services reviewed external device function as well as device description/function, therapy expectations and programming and stimulation considerations with the caller and the caller was able to connect to see the patient's settings.The therapy was on and the external devices were functioning as intended.The caller stated the health care provider (hcp) had told them that they could make changes to the settings if they needed and opted to increase the stimulation.The patient stated they felt the stimulation and it was comfortable but it wasn't in the bike-seat region, it was in their hip right at the incision of the ins.Patient services reviewed stimulation considerations again and the patient stated they'd never been able to feel the stimulation in the bike-seat, that they'd always felt it at the ins site by the incision when they felt it.The caller also explained that the patient has had several spinal fusions and so the patient's nerves "down there" didn't function as they should.The caller stated they were going to try to locate a program where the patient could feel the stimulation in their bike-seat region and also noted they would reach out to the patient's health care provider (hcp) about the issue, but they were going to continue to monitor the patient's symptoms in the meantime.Documented the reported event.No further action was taken by patient services. patient services also wanted to note that when the caller was searching for the ins site while they were connecting, they stated they saw the "scar" of the ins incision and was able to locate the ins site.

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: 18805422
• MDR Text Key: 336987527
• Report Number: 3004209178-2024-05960
• 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: 02/29/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• Date Device Manufactured: 10/30/2023
• 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: 75 YR
• Patient Sex: Female