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

Model Number 97800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Pain (1994); Skin Erosion (2075); Urinary Frequency (2275); Discomfort (2330); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 05/16/2022

Event Type  Injury  

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/bowel dysfunction and urge incontinence.It was reported that they are still on the fence.Patient said the device seems to be working but they are not sure as they didn't know how much the device is working.Patient said they feel a pulling sensation that turns into a pain which makes it hard to sleep.Patient said the nagging keeps them awake.Patient said they seem to feel the pulling sensation mostly when they are laying down.Patient said they have irritable bladder.Patient said their symptoms may have been anxiety induced.Patient said sometimes they get a sensation in their toe or thigh above knee, patient said it happens several times a day.Reviewed option to decrease stim or turn off. 2022-aug-04 additional information was received from the patient.The patient said when they were away they had a bladder infection which was painful.Patient said they felt electric shocks.Patient turned stim off and the shocks weren't as bad.Patient thinks they were misdiagnosed and have interstitial cystitis (ic).Patient said it seems like the ic is the cause for the frequent urination.Patient said that their back was more sore form the surgery.Patient said the device causes pain if stim is too high.Patient has been keeping stim turned off because it doesn't make much of a difference.Patient has had an increase in back and groin pain.Patient is thinking of having the device removed.Patient said when they got bladder infections they had to urinate more and it hurt to hold it.Patient has had to turn stim off several nights because of pain, patient changed programs and it seemed to be better.Patient said they go to a naturopath and a pelvic therapy.Patient said the naturopath seems to be helping most.Troubleshooting redirected patient to hcp to discuss removing the device.2022-aug-17 additional information was received from the patient.Patient said their current doctor who manages their device is not calling them back.The patient repeated the same information as before.Patient tends to have much more pain when they have the stimulation on.Patient was given exercises from their physical therapist but they cause too much pain.When they do certain exercises it is painful when stimulation is off.Pain goes away if they don't do exercises for a few days.Patient said they are not doing bending or stretching.Therapist said not to do exercises for a couple months.It has been three months.When stimulation is turned off the pain radiates down their leg, in their back, their buttocks, and the side of their hip and lasts a couple days if they stop exercises.When patient turns down stimulation it helps pain in their bicycle seat area.When they turn stimulation off the pain is less in bicycle area.The pain limits their movements.Patient feels they need a cystoscopy to diagnose if they has interstitial cystitis.Patient currently has the stimulation off.The patient has an appointment with their current managing doctor at the end of (b)(6).Patient also noted they have an appointment in (b)(6) with a urogynecologist.Patient mentioned again about the bladder infection when they were in switzerland.When they had a bladder infection they said the stimulator didn't work.Patient felt stabbing electrical sensation in the bicycle seat area.It did help to turn the device off.They gave the patient antibiotics and it calmed things down.Patient thinks the device exacerbated it.The bladder infections in switzerland was on (b)(6) 2022.Patient stated they need to have this out.Not able to get in contact with their doctor.On 2022-09-30 additional information was received from the patient.They reported that the device was causing pain down the leg foot and lower back.It was turned off for 4 weeks which helped slightly.The cause of the pain was unknown and the device was removed.The patient they had the interstim system removed 11 days ago due to the difficulties they experienced.Patient noted their doctor was returning the explanted the device to medtronic.Patient also reported they developed a small ulcer near the vaginal opening which was exactly where they felt the tugging of the stimulation.The patient's doctor was wondering if the ulcer could have been caused by the interstim.Reviewed adverse event information.[see related (b)(4) - trial pulling].

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 15542382
• MDR Text Key: 301167740
• Report Number: 3004209178-2022-12880
• 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: 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
• Report Date: 10/05/2022

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: 09/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/05/2022
• Date Device Manufactured: 03/24/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 63 KG