MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Battery Problem (2885); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Distress (2329); Discomfort (2330)

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 gastrointestinal/ pelvic floor.It was reported that patient reported they hadn't gone to their urologist since they got the device implanted.They confirmed their previous ins was replaced due to normal battery depletion and when they got their current ins they were told it would last for 10 years.The patient state they would keep their therapy level at.3 or.4 v and that it would help with their bladder pain and if they felt the bladder pain their spouse would help them raise the stimulation level a little bit.The patient stated they would typically raise it "once in a blue moon" or once a year or so and the last time they raised the stimulation had been about a year ago.The patient also reported that on occasion when they were in certain positions, they would feel the ins (the "box") "pop" out and it would bother them and then they'd shift positions and it would "pop" back in.The patient stated they would be at the movies and move and "be like "ow"" and that they thought that was just normal for the device.The patient stated that maybe about 6 months ago they started to notice bladder pain and so they tried to reach out to their implanting health care provider (hcp) however the hcp was no longer at the facility.The patient stated they did a consult with another urologist only to be told the urologist didn't work with the therapy so they worked with their insurance company to find another urologist and the patient was going to see another health care provider (hcp) on (b)(6) 2023 at loyola in illinois.The patient stated they stated a couple months ago they thought "uh oh" because they were feeling pain and that their spouse had tried to help them connect a couple days ago and even with new batteries in the programmer they saw "nothing." the patient couldn't confirm what screen the patient's spouse saw but confirmed the programmer was on and functioning.Patient services reviewed with the patient device longevity considerations and reviewed with the patient that their internal battery had likely reached end of life.The patient stated they thought it probably started dying a year ago and that they were going to follow up with a health care provider (hcp) to assess their situation and discuss getting a replacement.Documented reported event.No further action was taken by patient services. .

Event Description

Additional information was received from the patient.They called in and stated they would be sending the survey they got back with the questions they answered.Patient also restated information previously noted regarding their ins battery.Patient stated they saw a new hcp and are confused about the replacement process after speaking with the hcp.Patient had questions related to insurance and was directed to hcp or insurance company.Emailed list of physicians to patient and emailed the manufacturing field representative to request additional support for patient.In the response letter the patient stated when asked for cause that the battery was dead.Their hcp "checked and nothing so they were thinking the battery was dead." they need surgery to replace it with a new device.When asked what steps were taken to resolve the issue they stated that they went to the doctor on (b)(6) 2023 and decided to do surgery on (b)(6) 2024 to see what was wrong with the device and get a new implant.When asked what steps were taken to resolve theissue with the ins box popping out they stated that nothing had been done and it was just part of moving it.They included additional information stating that the hcp told them if they needed to get this for the first time they would not allow them to get it.They stated they were told they would need to physical therapy first.Since they have the insurance that will cover it.They also needed to log in on a paper to report how much urine came out and how much they were drinking for insurance purposes.They were not sure why they can't just set their surgery and change their battery.They stated it was so stressful and they needed to go back to see their doctor again to show them the log paper two weeks before their surgery.

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 INCON
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 18185702
• MDR Text Key: 328707277
• Report Number: 3004209178-2023-23085
• 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
• Report Date: 12/20/2023

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: 03/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/21/2023
• Date Device Manufactured: 09/26/2013
• 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 Sex: Female
• Patient Weight: 55 KG