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); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Ambulation Difficulties (2544); Paresthesia (4421)

Event Date 09/02/2020

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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported by the patient that the reason for their call was that the device had worked for the first couple days and then their urgency and incontinence had come back.It was noted that the agent did not ask about the circumstances that led to the reported issue.It was reviewed with the patient how to increase stimulation and the patient was able to increase stimulation to where they could feel stimulation.The patient was going to consult with their health care professional (hcp) about changing programs if their symptoms didn't improve.There were no further patient complications are anticipated or expected as a result of this event.Additional information was received from the patient.They reported ongoing lack of therapeutic effect which started about 5 or 6 days following implant.Patient met with the nurse at managing physician's office on october 8th and changed the program.Since that time, the patient has been experiencing overstimulation symptoms of discomfort in the buttocks and labia majora and still has a big urge to pee and urinary incontinence.They have decreased amplitude but still feel a disconcerting tightness in both buttocks and tingling and pulsating down the leg and into 2 toes as well as difficulty lifting up the right leg and getting into the car.Patient reports no falls or traumas.Recommended patient decrease amplitude down to a comfortable level and continue to monitor symptoms.Reviewed considerations regarding program use and recommended patient discuss with managing physician.Patient has a follow up on november 11th.

Event Description

Additional information was received from the patient.They reported that the evaluation was perfect and the implant was effective for about three weeks.The nurse practitioner gave them permission to change the program, and every time they changed the program, the device was effective for about ten days, and then symptoms would return.If they tried to increase stimulation, they would get a pain in the right labia and right buttock.It felt like the muscle in the buttock was in a knot.They had access to programs 1-5 and had tried them all.They got the message to go to the bathroom, and then they would stand up and urinate.They were currently filling an adult diaper every 1.5-2 hours without taking their diuretic.It was recommended they follow up to have programs 6 and 7 added and possibly see if a manufacturer representative could be at the appointment.

Manufacturer Narrative

H6: due to imdrf harmonization, some previously submitted device, patient, method, result, and conclusion codes related to this event may have been updated.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 patient.They stated their therapy only benefits them 3-5 days after they change their program.Then they are right back to the way they were before they got the implant.The doctor said they have already given them all the programs there is.Patient said they had one customized program and then programs 1-7.They said this has been an ongoing problem.Was good for 3-4 months and then struggled with it since then.Patient services asked after they get return of symptoms if they increasing the stimulation.They said, they can't increase the stimulation because it is already as intense as they can handle.They are tired of peeing in their depends and urine running down their leg.They wanted to know what they could do.They do not think the doctor and physician assistant know that much about the device.Sent message to medtronic representative to see if they could call the patient.On (b)(6) 2022 they stated they are still having problems having it work more than 3-4 days.They haven't heard anything from anybody.Sent the email again to the field representatives.

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 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
• 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: 10730998
• MDR Text Key: 219569833
• Report Number: 3004209178-2020-18610
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,Followup,Followup
• Report Date: 06/03/2022

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: 09/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 02/12/2021; 05/17/2022
• Supplement Dates FDA Received: 02/25/2021; 06/03/2022
• Date Device Manufactured: 03/20/2020
• 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 Age: 67 YR
• Patient Sex: Female