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

Model Number 97800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fatigue (1849); Pain (1994); Discomfort (2330); Malaise (2359); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinar y/bowel dysfunction.It was reported that they had been having some issues.The patient then further clarified the "issues," and stated that since implant, they have never felt good, that everything was sore and initially they attributed it to the surgery and accepted that it was expected to be sore and that their managing health care provider (hcp) told them everything would heal up, but they never felt better.The patient stated they wouldn't say they were the "perfect patient" because they were an ¿active 60 year old," and they had a job where they had to sit down all the time but they started to feel "pricking feelings" down near their bottom that felt like a needle pricking them, and then the tailbone started aching really bad recently.The patient stated it occurred when they moved certain ways and then probably in about the last 2 weeks, they started experiencing shocking coming from the ins site.The patient stated that yesterday they felt a shock that started at the ins site, went through their right hip and went across their legs and it sent a shock all up their right side and that it happened all of the time in different areas and it was wearing them out.The patient stated they tried turning the stimulation down 2 separate times and at one point they even had it off for 4 days, but even with it off, their tailbone "where they tell you where it (the device) is" was still sore.It was still so sore.The patient denied having had any traumas or falls that would have led to the issue and that it happened more gradually and didn't come on suddenly and that their managing health care provider (hcp) had gotten all of their complaints as they started.The patient stated they saw the hcp's physician assistant on (b)(6) 2023 and kelly told the patient they would have the hcp call them back but the patient never heard anything.The patient stated they told the nurse practitioner (np) about the constant aching in the small of their back and left buttock, occasional pricks in their pelvis area, weakness in " " (patient stated something that sounded like "dle" but patient services could not make out what the patient said exactly), generalized fatigue, and that they were only taking ibuprofen and that they hadn't tried anything else.Patient services reviewed the different programs that were available for the patient to try to see if they ran into the same issue with each program but redirected the patient to follow up with their health care provider (hcp) about the issue to check the implanted system.The patient stated they had just turned the therapy off before calling patient services and stated that because it was off, they were peeing now but with it on, though the therapy helped their symptoms, they had the aggravation of the pain.The patient stated they had an appointment with their hcp scheduled for (b)(6) 2023, but they didn't know if they could wait that long.Patient services redirected the patient to contact their hcp office again and patient stated they would call their hcp at the end of the call with patient services about their concern and to discuss also potentially trying a different program in the meantime.

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: 17351922
• MDR Text Key: 319977861
• Report Number: 3004209178-2023-12917
• 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: 07/19/2023

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: 02/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/19/2023
• Date Device Manufactured: 08/25/2022
• 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: 60 YR
• Patient Sex: Female