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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

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.

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.It was reported that patient thinks they have damaged something.Started out at.5v.They then lowered it to.4 v for a short time.Then raised it to.5, and then to.6, and then down to.5.On (b)(6) 2022 they were in the bathroom and hit the door frame and hit the neuro stimulator and had pain for a couple days and then was fine.After that the therapy didn't give them any time from stimulation and relief of bladder, but then calmed down after a couple days.Patient still doesn't feel right.On wednesday (b)(6) 2022 patient went and had a dental appointment and didn't turn off the stimulation.Patient had a temporary crown put on.When they went back out to the car when they were done, they realized they should have turned it off.They turned on handset and got an orange triangle that said possible electronics use.They turned off the whole system then turned on  the stimulation.They had charged the handset 100% the night before.It came down to 80%.They also charged the communicator, both to 100%.Since then they would get a single and immediate release of bladder or get a single and not very long.Patient put the stimulation up to.6v and couldn't feel anything so they put stimulation up to.7v and still didn't feel stim.They put it back down to.5v and then on saturday morning at 4:00am they turned everything off again because they were emptying bladder every 20-40 minutes.They do wear overnight pad with overnight diaper.Patient mentioned they do sleep hard so they don't always know when they would be emptying her bladder.Also since then, they had been up since 3am.They didn't want to go through this and turned the stimulation off.When turned whole system off, patient does get stimulation without it on.They can get to sit on toilet or get to the toilet with small leakage.They had small amount of control.Patient called healthcare professional (hcp) and was not in.They talked to the physician assistant, and they said to call medtronic.Patient put stimulation up to.9v this morning.Checked patient's current settings and was on program 1 at.5v.On the call patient increased the stimulation to 1.5v.Confirmed stimulation in bicycle seat area and comfortable.Patient will maintain stimulation level and will continue to track symptoms.

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.

Event Description

Additional information was received from the patient.In response to an inquiry to confirm that the ins was damaged after hitting the door frame, they reported that it had not/it was unknown.They had changed to another program which seemed to be working better after one day's use.They will have to continue to use and chart.Charts were kept for several weeks before doctor's appointment on 2022-(b)(6).The cause of not feeling stim when they upped to 0.6 and 0.7 was not determined.After the incident they had to raise to 2.5v (on 2022-(b)(6) and then lowered it (on 2022-(b)(6)) to 2.3, because of a deep pulsating feeling.They reprogrammed to # 2 (at 1.0 v) the same day in the doctor's office.They stated that the manufacturing rep had told them to keep it steady after raising it until this doctor's appointment.They will continue to chart for the next month and discuss on 2022-(b)(6).It was unknown if the issue was resolved.When asked if the implanted system was affected the dental crown procedure, the patient circled 'yes' and 'unknown'.With regard to how the implant was affected, they wrote that when they changed to program 2 all seems to being doing much better including sensations/alerts to their body.They said it was probably affected at the first visit because they had not read instructions to turn off the equipment.Charts show how it was not working correctly under program 1.They were going to continue to chart programs for one month on a new program.Level (2).The issue was not yet resolved.The cause of the whole system turning off, but the patient getting stimulation without it on was determined.It was user error probably.They were going to keep equipment in their car in the future and out of the dental office at their next visit on 2022-(b)(6).It was unknown if this issue was resolved.The cause of the orange triangle that said 'possible electronics use' was not determined.The patient was that the likely cause was user error.The equipment was not turned off and was approximately 10 feet from the patient while in the office.It was reiterated that the next dentist appointment will be 2022-mar-24.And the equipment will be left in the care and checked when the appointment is over.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 13563843
• MDR Text Key: 296393986
• Report Number: 3004209178-2022-02269
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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: 04/05/2022

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: 04/14/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/05/2022
• Date Device Manufactured: 10/14/2021
• 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
• Patient Weight: 76 KG