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

Model Number 3058

Device Problem Unstable (1667)

Patient Problems Muscular Rigidity (1968); Pain (1994); Twitching (2172); Urinary Frequency (2275); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 05/14/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The reason for call was patient has two implants.One is on the right side for urinary incontinence and the other is on the left side for fecal.Patient is having some nerve issues with the therapy.Where they are at now they are getting some relief.But now they can't sit up straight, or can't bend a certain kind of way because it makes the nerve in leg all the way down looks like a seizure.The device has flipped for some reason in the back.Their main concern is the nerve twitching.The leg goes in and out, but if they bend over it feels like having a seizure.It is over exercising the nerve.At a lower amplitude they were urinating too much, so brought the stimulation up to get more relief.Now to the point where they are at now it's not helping, so they are going to the bathroom a lot more.Only thing it is doing is the nerve thing.It has them jerking.They guess it is on a pulse system.It stays at a certain pulse.The pulse is going up and down, and her body is reacting to it like jumping a car and it is causing some problems.Sitting on edge of bed or in the bathroom, it is like a disorder where they can't control their movements.The leg moves like it wants to and can't calm down.Causing charlie horses in both her legs.Painful and get charlie horses while standing.When asked when this issue started, they said, it has maybe gone on for four months but the urgency has gotten worse.At first they adjusted it up and thought they had to get use to it.Was having frequent urination before the nerve issue.It feels like tension and it pulls.Left stimulator is for fecal.That one the amplitude was really low, and they were not getting any kind of relief from it at all.She brought up the amplitude.Stayed there for a while and was ok.Fecal side joined in when started having the neve issues.When brought the fecal side up started causing jerking, looks like tourette syndrome or seizures.Explained to the patient she might have the stimulation to high and that is causing the nerve issues and the return of symptoms.I suggested she try lowering the stimulation which relieved the nerve issues.The patient decided she wanted to change programs and she switched while on the call.Patient will maintain stimulation level and will continue to track symptoms.Confirmed stimulation in bicycle seat area and comfortable.(b)(6) 2022 lfc (hcp): additional information was received from a healthcare professional (hcp).The hcp reported that the patient was able to adjust placement to correct problem, and the issue has been resolved.No actual seizure activity occurred.The hcp also stated the urinating too much was the overactive bladder.

Manufacturer Narrative

Concomitant medical products: product id 3058, serial# (b)(4).Implanted: (b)(6) 2021.Product type implantable neurostimu lator date of event: date is estimated; year is 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.

• Brand Name: INTERSTIM II
• 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: 15513736
• MDR Text Key: 305894409
• Report Number: 3004209178-2022-12643
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: 09/29/2022

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: 05/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/30/2022
• Date Device Manufactured: 12/08/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 102 KG