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

Model Number 3058

Device Problem Energy Output Problem (1431)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Device Overstimulation of Tissue (1991); Urinary Retention (2119); Urinary Frequency (2275); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 11/09/2022

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 first received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation on (b)(6) 2022.It was reported that the patient was having trouble in the last few weeks controlling urine.They have talked to their healthcare provider (hcp) about it and have been told to call patient services (ps).On the call the patient d was successful to synching the device and said, they were on program 1 at 1.8 they said they wanted to lower the number and lowered it to 1.6.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.The patient's relevant medical history included patient goes to another urologist, because they have a tumor, cancer on their left kidney.The patient called back (b)(6) 2022 and reported that the adjustments made during the last call helped for a little while but now the symptoms have returned.Helped patient connect to the ins and increase the stim to a comfortable level.Additional information was received from the patient's healthcare provider (hcp) (b)(6) 2022.It was reported that the patient's tumor was not caused by or related to the device.The patient called back (b)(6) 2023 and reiterated their previously reported information, that starting sometime in 2022 the therapy hadn't been working right for their symptoms, that they'd been going to the bathroom a lot and leaking a lot and that they'd been having trouble lately.The patient stated they went to their managing health care provider (hcp) on (b)(6) 2023 and the hcp had the patient turn the therapy off for two weeks.The patient stated they were catheterizing themselves 3 times a day to see if they were leaking.The patient ended the call with the intention to call their hcp office to ask them about their battery longevity because they hoped to replace their current system with an mri safe system when the battery depleted.Pt called back (b)(6) 2023.Reporting they are still having therapy issues.Pt reported having trouble with hurting across their bladder and leaking some.Pt wanted assistance with increasing therapy setting.Reviewed therapy overview and patient successfully synced with implant on the call and confirmed therapy was on.Pt made a comment that they felt stimulation when they synced with their implant.Pt increased stimulation to a comfortable level.Patient will maintain stimulation level and will continue to track symptoms.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Pt stated they have followed up with their physician's office to check ins battery status.Pt stated their np is having pt do a catheter test at home where pt goes to the bathroom and then uses a catheter to see how many ccs are left as pt stated they might not be emptying completely.Pt stated they go back to np in 4 weeks (b)(6) but stated they are going to call today to see if they can go back earlier.Pt also mentioned at the end of july pt had a ct scan that checked both pt's kidneys and bladder and stated it came out "good".Pt confirmed this is all a continuation of event previously reported in this case.Patient called back stating stim was too much and wanted to know if they can decrease stim.Reviewed how to decrease stim.

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.

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.

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 the patient.The patient called back indicating they followed up with managing hcp and were told there is over a year left on the ins battery so that is not the cause of the therapy concerns.Patient stated it still does not seem like therapy is working because they are having to use the bathroom more and patient wondered if they are on the right setting.They feel stimulation more towards their rectum on the current program.Ps reviewed how to change programs.Patient confirmed they felt stimulation in the pelvic floor and is comfortable on the new program.They will monitor symptoms.Patient called back and stated that they are having trouble with leakage and that yesterday they started having to go to the bathroom a lot again.Patient said they had called on the 18th of august and had changed programs and that seemed to work until yesterday.Patient said their hcptold them they have 5-6 months left on ins battery.Patient stated it seems like their symptoms return in the afternoon.Patient was able to connect to ins after some repositioning.Patient was able to increase stimulation to a comfortable level.Patient will maintain stimulation and monitor symptoms.Patient called back and said still having trouble controlling urine, said that it just starts coming out.Patient said it is better in the morning however gets up at least two times at night and has been like this for about two weeks.Patient said last adjustment was on (b)(6) 2023.Reviewed therapy information and general programming guidance.With instruction patient switched programs as patient has reached upper limit comfort wise on current program.Patient to monitor and track symptoms for a few days.

• 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: 17504849
• MDR Text Key: 320863589
• Report Number: 3004209178-2023-14123
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2023

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: 08/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 08/16/2023; 08/18/2023
• Supplement Dates FDA Received: 08/16/2023; 08/17/2023; 09/13/2023
• Date Device Manufactured: 02/21/2017
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 55 KG