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

Model Number 97800

Device Problems Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Incontinence (1928); Itching Sensation (1943); Pain (1994); Anxiety (2328); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence.It was r eported that their case manager suggested that caller talk to a manufacturing representative (rep) about their situation.Caller stated they noticed issues with ins "two, three weeks" after implant.Caller said they have "discharge" from their vagina and that it is "clear" and "itches very badly it hurts if i scratch it".Caller mentioned that "every once in awhile" they get a pain in their anus and that it "one of the main worries on my part".Caller also stated that they "don't know if a poop will roll out" and that sometimes they can't make it to the bathroom to pee.Caller also said they "pee differently" and not how they used to.Caller said when they pee it "trickle trickle trickles slowly" and then they have to go a second time "probably half hour to a hour" later they pee "normal".Caller said that their doctor did a "pressure adjustment" or patient later referred to it as a "pressure push".Caller said it "opened up the world with itchy things all over me" and "did something to the anus and something to my vagina".Caller said that after that was done they are "afraid of everything" in regards to their ins.Caller said when they had returned to the doctor.They thought they would fix ins surgically.Caller said when they sat down in their chair one time they "just about went three feet in the air" from pain near their tailbone.Caller was unable to remember when this "pressure adjustment" was done.Caller said a "guy" was on their hip and they developed a boil after the "pressure adjustment".Caller said they put a pain patch on area because it "hurt so bad".Caller said the area is still tender.Caller said they are supposed to have spinal surgery, but that doctor told them they need to get ins corrected before they can have surgery.Caller said when they first got ins they were "very satisfied" but "years later the internal battery was going askew".Caller confirmed they have had two ins.Caller mentioned they were not trained on their most recent ins.Caller stated they had tried reaching out to hcp but "waited weeks and weeks no one called me".Caller mentioned having spoken with mdt rep "ryan sims", but agent gathered this was in relation to their old device.Walked caller through options for making a therapy adjustment.Caller stated they were nervous to make stimulation increase as their vagina is "swollen" on both sides and that was where they had previously felt stimulation.Caller decided they wanted to try turning ins off.Walked caller through how to turn ins off.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.Notifying field staff of situation or request.They also stated they fell in their apartment and were "on the floor for two days" and they "don't have proper knees".Patient said they went to the hospital.Patient did not remember when the fall took place, but said it was after implant of ins.On (b)(6)2023 the patient called back and stated they did turn stimulation off with the previous agent and their vagina isn't hurting as much but still has a burning sensation.Currently their plan is to take medication since their stimulator is turned off.

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 the healthcare provider (hcp).When asked about what the patient meant when stating a "pressure adjustment" or a "pressure push", the doctor stated they were not sure what the patient was referring to.They were last seen in clinic in (b)(6) of 2023.At that time, the device had been turned off by the patient.They turned it back on and it caused no pain/symptoms.It was unknown if the pressure adjustment/pressure push was related to the device/therapy.Device revision/replacement is not planned.The issue is not resolved but no further action will be taken.

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.

• Brand Name: INTERSTIM X
• 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: 17004173
• MDR Text Key: 316787706
• Report Number: 3004209178-2023-07096
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/23/2023
• Date Device Manufactured: 04/27/2022
• 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 Sex: Female