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

Model Number 3058

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Irritability (2421); Sleep Dysfunction (2517); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Therapy information and general programming guidance was reviewed.They patient was going to adjust settings and monitor symptoms.Patient reported they were sensitive to the stimulation sensation and it was annoying.Additional information was received from the patient.They reported they had noticed a change in their bowel functions and that they had seen doctors due to this.The role of the help line was reviewed and the patient was redirected to their healthcare provider to discuss their symptoms and further address the issue.Adverse event information was also reviewed.The patient stated their bowel function was "not normal before this started and now it was even worse." this started last year.They had not seen their doctor since last year.They again mentioned they had not experienced any improvement in symptoms since getting the implant.They stated, "nothing seems to be working for me.Suffering is not even close to what i've been going through." they only slept four hours per night and would wake up wet and uncomfortable.They had huge anxiety about this entire thing and were miserable.They had tried all available programs and reported four programs "did absolutely nothing," and the current program they had been on since they thought november of last year made maybe a 20% improvement for a few months.Now it was "maybe a 10% improvement." they had been to four doctors due to this.They had been told to "try all the programs" and to try different settings.The healthcare provider had advised them to call the help line to discuss what changes to make to therapy and to help with this.The role of the help line was again reviewed, along with a therapy overview.The role of the manufacturer representative was also reviewed along with the process to coordinate an appointment with the representative.The patient mentioned they had first worked with a representative regarding this and then another representative that also told them to try different programs due to this.Since trying to make changes due to this, if they were sitting in a certain position in a chair, they could feel stimulation "pulsing," and it drove them crazy.When trying to sleep at night, if they were lying on their left side, they could feel stimulation pulsing and could not fall asleep.They confirmed they were referring to feeling stimulation in the bicycle seat area.They stated it was likely up too high since it was painful.If they decreased it, the pain went away, but did not help with symptoms.They clarified that it did not help either way.If they tried to increase stimulation to try to help with symptoms and tried to deal with it being uncomfortable, it did not help with their symptoms.They confirmed this was all a continuation of the previously reported event.Their relevant medical history included having pelvic pain that had nothing to do with the issue noted above.Their healthcare provider thought it was due to a hernia.They also had a history of orthopedic issues (not alleged to be related to device/therapy).Five days later, they called back and repeated their therapy concerns.They increased amplitude and it was uncomfortable and annoying to them.They could not feel when they needed to urinate or have a bowel movement, which was upsetting and they could not eat or sleep.They also had pelvic pain which started in january.They went to pelvic floor physical therapy and that did not help.They had a history of endometriosis and gynecological issues and one of their doctors thought they had a hernia (not alleged to be related to device/therapy).They had a urodynamics test in december of last year and had minimal improvement, but the doctor at that time did not believe the patient when they said they were still having symptoms.They ended up seeing a psychiatrist for a year and stated why would they make this up? they had been put on different medications which were not effective (not alleged to be related to device/therapy).They had seen multiple doctors and one of them was wanting to order an mri to try and determine the cause of the pelvic pain.They were seeing a new physician who would be setting up an appointment for the patient to meet with a manufacturer representative in order to add new programs for them to try.General theory and use of programs was reviewed, as well as therapy expectations.

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.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 a healthcare professional (hcp).The hcp reported that the cause of the intermittent pulsing stimulation and body posture affecting the stimulation was unknown.It was unclear at this time.The patient was seeing another urologist.The cause of the stim being too high was not determined.The las office visit that the healthcare professional (hcp) had seen the patient was (b)(6) 2020.The suicidality (comments about ending their life) were not related to the device/therapy.The pelvic pain, hernia, need for floor physical therapy, orthopedic issues, etc, were not related to the device/therapy.

• 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
• MDR Report Key: 12028717
• MDR Text Key: 266707171
• Report Number: 3004209178-2021-09635
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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: 09/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 54