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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Inadequate Instructions for Non-Healthcare Professional (2956); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Flatus (1865); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Constipation (3274)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from a health care professional via a manufacturer representative.It was reported that the patient was unable to remember the exact date of the fall in (b)(6) 2019, but that the system was not impacted in any way after the fall.The patient had a lipoma near the pocket site surgically removed, and no disturbance of the system was noted during the procedure.No device issue had occurred because of the fall.The patient reported not feeling stimulation due to normal stimulation expectation.The patient increased stimulation amplitude and stimulation as felt appropriately.The system ins and lead, remain with no change.There are no plans for device explant.It was reported that the patient was pleased with therapy relief.No further complications were reported or expected."mdr decision updated to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.".

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.The patient reported that her reason for calling was to get an explanation on what the different programs were for.The patient noted that she was on program 3.The patient stated that she reached out to the healthcare provider (hcp) for further assistance, but was directed to call patient services (by the hcp).The patient stated that the hcp provided a pill to help with the bladder symptoms during the day, but noted the pill did not help at night.Patient services reviewed programs, considerations with changing settings, and the therapy with the patient.The patient indicated that she understood and was never trained adequately on how the therapy worked.The patient reported that the manufacturer representative (rep) never fully explained to her what the different programs did, and that she needed more assurance/information from the manufacturer representative (rep) on the therapy.The patient noted that she didn't have a clear understanding of what to expect with the ins.The patient reported that she has the ins for bowel control, but the healthcare provider (hcp) told her that the ins would help with both her bowel and bladder function.The patient reported that she had utis (prior to implant) every 2-3 months, would have "terrible impaction that was uncomfortable¿, would pass gas and mark her drawers.The patient stated that she would be on an antibiotic to address the utis.The patient would tell patient services at one point in the call, that she was getting better than 50% symptom control, but in other parts of the call, the patient would report that she would have accidents while out with her family.The patient noted again that she went through all 7 programs during the course of one day, and that she felt a fluttering from the stimulation.Patient services reviewed the therapy once more with the patient and offered to provide assistance over the phone, but the patient declined.The patient stated that they will monitor her symptoms and track therapy progression.During the call, the patient noted that she knew what stimulation was not supposed to feel like, because of an educational demonstration with the manufacturer representative (rep).The patient indicated that she was able to resolve this with the rep by adjusting the settings.No further complications were anticipated /reported.Additional information was received from the consumer on 2020-mar-11.The patient reported they had gotten the implant because they had been having a urinary tract infection every six weeks for three years (not related to the device/therapy).The patient stated the device was for fecal incontinence and that it did correct the issue.The patient reported a loss of therapeutic effect; said a couple months ago (2020) they started having little traces in their drawers, ¿not explosions.¿ the caller stated that when they implanted the device ((b)(6) 2019) that the health care physician (hcp) took out a ¿live lipoma, a fatty tumor,¿ (unrelated to the device/therapy) because it had been causing them distress and pain.The patient stated that it must not have healed correctly and filled with fluid.The patient reported that they had fallen on (b)(6) 2019 and had landed on their right side (on a steel dog bowl) where the ins was and they were afraid they had injured the ins.The hcp then went in surgically and checked the wires and the patient had a cyst (unrelated to the device/therapy) so the hcp put in a drain on (b)(6) 2019, removed the drain on (b)(6) 2019 and ¿it started swelling up back there.¿ (unrelated to the device/therapy) the patient reported that they had gone to a dermatologist and they said that it was too big to remove and they did an ultrasound.The patient stated they thought the doctor had called it a seroma.The patient was then referred back to their surgeon, who drained it on (b)(6) 2020.The surgeon thought that once they drained it the interstim would go back to functioning like it should.The surgeon had thought that the swelling was compromising the interstim.The patient reported that they didn¿t know they had a bowel movement until they smelled it.The patient noted that they were numb ¿down there,¿ but noted that it had been like that since before the implant.The patient had been on program 3 at.4 volts and the patient reported that they had increased it and didn¿t feel anything until they got to.8 volts where it was ¿very slight.¿ it was noted that now the patient was having the issue again and the patient called their hcp who had told them to reboot the handset.The patient rebooted the handset and it didn¿t resolve the issue of feeling stimulation.The patient¿s settings were checked on the call and they were noted to be on program 3 at.7 volts.While on the call the patient increased to 1.2 volts.The patient was advised to monitor their symptoms for a couple days in their diary and see if their symptoms improved.There were no further complications reported.

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 a manufacturer representative (rep).The rep reported that it had not been explanted to their knowledge.There were no further complications reported.

• 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: 9879644
• MDR Text Key: 188944824
• Report Number: 3004209178-2020-06133
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

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: 12/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 04/17/2020
• Supplement Dates FDA Received: 04/16/2020; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR