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); Energy Output Problem (1431); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

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 implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The patient reported that her therapy was working well, but shortly after implant, she felt spasms stating that the healthcare professional (hcp) told it might have something to do with strong antibiotics.The patient mentioned the hcp told her to take tylenol and motrin following implant which she did not do, so 2 days after implant, she had spasms that felt like labor pain.The patient also mentioned she took tylenol and motrin and once they hit her system she "didn't have anything like that" again.The patient also mentioned during call, she hasn't been many places because she hasn't felt too well".She mentioned she was "very impressed" with implant stating, "it changed things for her a great deal".Additionally, the patient called asking questions regarding patient programmer and ins considerations for security devices.The patient mentioned she was trained regarding security devices by manufacturing representative (rep) under anesthesia.Additional information was received from a consumer.It was stated that the doctor set the stim two weeks after implant and they thought it was great.They had the device for bowel and the bladder, and it worked for maybe a week and a half, no pain or leakage, and then all of a sudden it didn¿t work.The patient did not feel they had gotten better; they still had symptoms of leakage, but ¿at times it helps.¿ it was again reported that they had spasms or contractions in their back like labor pain.It was also stated that they had issues with pain with the stimulator on their lower back and down their left leg.Specifically, that they were in so much pain on (b)(6) 2019.Troubleshooting had already included calling and going to their healthcare provider on several occasions.It was noted that their healthcare provider would adjust it and send them home, and the patient wouldn¿t feel the pain until ¿maybe the next day.¿ the patient had met with the rep in (b)(6) 2019; they stim was on during that whole timeframe, but they may have adjusted it.The highest the stimulation had been was 0.85; they didn¿t keep it very high.The rep mentioned that the patient being small might be part of what was causing the pain, but it was noted that they had not taken any images of the system.The rep showed the patient how to change programs at their november appointment.It was reported that the patient had a lot of pain with ¿left side¿ two days ago and took tylenol and ibuprofen.They stated that they never had this pain before the implant.They had to turn the stim off because they had a lot of really bad pain, and it had been off for two days.It was stated that they still had the same pain with the stim off, but it wasn¿t as intense.They had called the nurse, but they didn¿t know why they would still be feeling pain if the stimulator was off.The patient stated that they would start over and try again, they thought with program 1, and track in a diary to see if they get relief of pain and symptoms.It was recommended that they follow up with their healthcare provider about their pain.No further patient complications are anticipated or expected as a result of this event.

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.

Event Description

Additional information was received from the patient.They reported having a lot of problems with the system since implant: they had been in pain for almost 2 years and it feels awful.They had some pain maybe 2-3 weeks after the surgery, and they had so much pain on (b)(6) 2019 that they couldn¿t go out to eat.In (b)(6) 2020, they met with a manufacturer representative, but the rep didn¿t think they could do anything else for the patient.The patient stated that the leg pain and therapy were horrible; they felt the same way as they did before the device, but now they have left leg pain which they didn¿t have before.Troubleshooting had included turning the therapy off ¿almost a month ago ,¿ and they noticed some pain relief almost that same day; their leg had felt great since turning off the therapy.However, on the day of the call, their hip hurt and their leg felt the same way it did when therapy was on.Their toes were tingly on the left side and their left hip almost felt like something was poking at them sometimes.They checked the device and therapy was back on by itself.They turned therapy back off around 7:30 am and noticed a decrease in hip pain, but still had some pain, from thigh into foot.It was noted that their hcp had not yet done an x-ray.The hcp wanted to replace the device, but the patient didn¿t want that.They stated that they just hope they can have it removed.It didn¿t really help; it just caused more problems.

• 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: 9582680
• MDR Text Key: 192411266
• Report Number: 3004209178-2020-00929
• 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
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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: 06/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR