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

Model Number 97800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Incontinence (1928); Distress (2329); Dysuria (2684); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary and bowel dysfunction and urge incontinence.It was reported that in the last few days, it doesn't seem like the device is working at all as the patient is leaking urine constantly.The patient said that the pads come out full of urine.When asked, there were no changes to diet, stress level, or medical conditions.The patient, however, said that about a week ago she saw a primary care doctor and was given a prescription for zoloft for stress.Reviewed therapy information and general programming guidance.The patient will maintain stimulation levels and will continue to track symptoms.The patient will contact their primary care doctor to review the side effects of the new medication and, based on the information, make adjustments to their settings and track symptoms.On november 8, 2023, additional information was received from the patient.The reason for the call was that the patient said they have been having a lot of leakage the last week or so, and they are not getting any indication that the device is not working.The patient mentioned they want to get greater than 50% symptom relief.Please note that the patient stated they are getting 50% symptom relief but also mentioned symptoms getting worse this past week or so.The patient mentioned that they have not been sleeping very well.The patient also mentioned that it takes forever to bring up the therapy, and sometimes when they finally get a good connection, it is pretty hard to get it to connect.Patient said they will feel if ins feels "warm" or "cold".Patient has checked the battery levels of the external devices and has done that once or twice in the last week or so.Reviewed therapy adjustment options.The patient was redirected to their healthcare provider to further address the issue.Patient will maintain stimulation level and will continue to track symptoms.Please note patient was difficult to follow and agent did their best to document and answer their questions.Patient mentioned they have an appointment with hcp in december and will review questions with them as well.

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 repeating therapy related concerns.Since getting the device, they had been able to reduce their pad usage however wondered why their urine was hot and reported their pad was soaked after a 2 hour trip away from home.Patient also inquired about the difference between urge and stress incontinence and stated they had been stressed out lately.Patient services reviewed information and redirected to healthcare provider (hcp).Patient was concerned that their communicator was not working properly, stating that over the weekend they could not get the communicator to power off.Patient services determined this was because patient was not using the communicator properly and did not understand the power button needs to be held down for several seconds to power down.Patient services reviewed during the call and the communicator was working normally and as designed.Patient called back on (b)(6) 2024 saying they were having trouble with the communicator.They called a w eek ago and couldn't get communicator to shut off.They used the same program and it was not doing anything- not getting therapy relief and they produced less urine.Patient said they knew when it was working.They said the communicator was not damaged, but it was not loading the program.Agent confirmed that they could connect to stimulator and get the program and amplitude to display, and explained that means the external equipment is working.They kept saying when they talked to the agent last week they said if it doesn't work they can call back and get it replaced.They let it got for a week and tried lowering and raising the amplitude.Patient thought the communicator was not working.They said the yellow light wouldn't go off.Patient services told them that meant the communicator was low and needed to be charged.They said they charged the communicator and it said 100%, so did the handset, and the stimulator said ok.Patient was adamant about getting the communicator replaced.Patient services sent email request to repair.

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 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: 18111726
• MDR Text Key: 328043604
• Report Number: 3004209178-2023-20166
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 08/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/12/2024
• Date Device Manufactured: 03/03/2022
• 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 Age: 83 YR
• Patient Sex: Male