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

Model Number 97810

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Urinary Frequency (2275); Urinary Incontinence (4572)

Event Date 04/26/2022

Event Type  malfunction  

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 a couple months ago, the patient noticed that the charging cord for the docking station didn't fit in very well and it was hard to charge their recharger and then connect the recharger to their ins.Patient said they have to move it and jiggle it around a little to get it to charge but it didn't always stay powered on.Patient said they thought it was the cord but not entirely sure if it's the cord or docking station.Patient said they seemed to get "enough juice" out of the docking station to charge their recharger so they can charge their ins, but they could only get it to one battery bar.Patient said they had problems connecting to their ins with their recharger and have had issues since implant.Patient said at first they tried to charge their ins every week but were having to charge it every 3-4 days now because their ins battery went from 100% to 70% in 3-4 day s.Patient said when their ins battery got to 60-70%, they noticed the ins wasn't working as well and they were having more accidents.Patient said the implant had kind of worked ok since implant, but they had never been able to come out of diapers.Patient said some days they would try to just use a pad and that'll be the day the ins didn't work right.Patient said yesterday they were out all day and everything was fine but when they went to sleep at night, the ins quit working andthey woke up to urinate 3-4 times and they urinated on themselves all the way to the bathroom.Patient said they tried connecting to their ins last night after their accidents and found that the therapy was turned off.Patient said they turned therapy back on today and increased stimulation to a comfortable level and later on in the day they noticed the ins was sending pain to their stomach.Patient said they've gotten the best therapy relief on program 7 so when they connected with their ins to adjust for the pain and make sure they were on that program, they weren't able to access their programs.Patient said they did not see program 7 or any button to access the programs. patient said they noticed this today, as well.Patient said they texted a manufacturer representative (rep)today in regards to not seeing the programs but hadn't heard back.Patient services reviewed amplitude vs ins battery depletion, as well as ins battery % in relation to therapy relief.Patient services reviewed what happens when the ins battery depletes and reviewed therapy optimization options in regards to pain patient is experiencing and connected with healthcare it (hcit) to see if patient's therapy applications needed to be updated and if that would solve issue of not seeing programs in their therapy application.Hcit did confirm apps needed to be updated and helped patient update them.Patient re-connecting with their ins and still could not see programs.Patient services recommended patient decrease stimulation or turn ins off to determine pain and monitor symptoms and redirected to healthcare provider (hcp) to help with reprogramming and discuss pain symptoms.Patient said they will wait for response from rep and follow up with hcp.Patient services also sent new docking station cord and told patient to call back if the new cord did not resolve the issue.

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.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.Patient said that their managing physician redirected patient to contact [manufacturer] to schedule an appointment to add programs.An email was sent to field staff, who responded stating they called and spoke with the patient.

• Brand Name: INTERSTIM
• 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: 17134922
• MDR Text Key: 317296780
• Report Number: 3004209178-2023-10919
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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: 08/30/2023

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: 02/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/30/2023
• Date Device Manufactured: 08/16/2021
• 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: 69 YR
• Patient Sex: Female