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

Model Number 3058

Device Problems Loss of Data (2903); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that whey they first got the device it was wonderful then eventually it was terrible and they called in probably 5-6 weeks ago who told the patient they could add two extra programs a and b and told them to try a for a month.Pt said they were calling because a did not help them at all and they want to activate b now but can't find it.Worked with pt to synch with their ins and navigate to their program menu, pt had 1 through 7 but there was no a nor b.Reviewed with pt: they would see the programs they have the option to activate if a and b are not visible they are not currently available to use.Patient stated that they had also worked with the np at the doctor's office.Pt asked what could be done further with ins to try and improve their symptoms.Reviewed there is potential for additional programming that could be added at an in person appoint ment.Reviewed their doctor or the np at the office could page a representative to meet the patient at the doctor's office and add further programming.The caller was redirected to follow up with their healthcare provider to further address the issue. the patient called back and reiterated previously reported information.The patient reported they've had "problems with the stimulator working" and that close to a month ago had to have an mri and had to learn how to turn off the device and called in and got that information, it worked fine and the person they talked to said "he told put on two extra programs a and b" so they started with a and "he said keep it on a for a week" and the patient did that but they went to find program b and couldn't find it and now they could not find either program a or b now.The patient stated they were in a quandary.The patient stated they didn't have the name of the person who they spoke with.

Manufacturer Narrative

Year is confirmed valid.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.When asked about the cause of them no longer having programs a and b they stated that it was not known but that a person they talked to about the device not working was able to bring up a and b.They stated they were told to use a for four weeks and then switch.A did no work but they could not find b nor could anyone at the manufacturing company.When asked what steps were taken to resolve the issue they stated that they were away for a week at thanksgiving but will reach out to their doctor tomorrow ((b)(6) 2023) and see if they could help.This issue had not yet been resolved.When asked for clarification on the stimulator not working the patient stated that at first it did a good job in controlling their overactive bladder symptoms but in the last 6 months or so the symptoms were not controlled at all.They stated it was unknown if this was caused by normal battery depletion and that the cause was not known.When asked what steps would be taken to resolve the issue they stated that they would contact their hcp and go from there.

• Brand Name: INTERSTIM II
• 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: 18159620
• MDR Text Key: 328488557
• Report Number: 3004209178-2023-22122
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2023
• Date Device Manufactured: 04/21/2021
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 62 KG