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

Model Number 97800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Urinary Retention (2119); Urinary Frequency (2275); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 02/16/2024

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 urinary/bowel dysfunction and urge incontinence.It was reported that they are not sure if they are doing it right or something is wrong.Friday morning and sunday morning they started peeing over themselves every few minutes and when they look at the programmer it says session timed out.Reviewed the meaning of the session timing out message.Helped caller connect to implant and increase settings.Caller will maintain stimulation and adjust as necessary.The caller also noted that they are still catching more than they are voiding.Additional information was received from the patient.Patient called back and repeated therapy issues as previously reported and documented, see call summary.Patient said has still goes every hour, sometimes it is 20 - 30 minutes, sometimes 45 minutes.Patient said is still having accidents, said went several times yesterday throughout the day.Patient also reported some fecal incontinence all day yesterday and today.Patient said that on the same day as the implant surgeon performed a cystoscopy and was patient was placed on an antibiotic for an extended period however wasn't told that has a uti and mentioned possibility of a parasite.Patient said was on an antibiotic during the trial.Patient mentioned history of utis.Patient said self caths three times a day, morning, afternoon and right before bed.Patient said that typically the volume in the afternoon is pretty low.When asked, patient made an adjustment yesterday and stated has tracked their adjustments.Reviewed therapy information including expectations and healing time factors.Reviewed general programming guidance.Patient decided is going to maintain current stimulation level and continue to monitor and track symptoms.Patient said that spoke to dan, the medtronic representative about two weeks ago (prior to implant).When asked, patient said that their follow up appointment isn't until march 25th.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.The h.6.Codes have been updated to reflect the new information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They did experience urinary retention prior to the device and their retention has not worsened as a result of the device/therapy.Catheterization was a standard of care prior to the device.The cause of the programmer saying session timed out was determined.They needed the explanation of why it was saying that message and that it did not mean that the therapy had stopped or turned off.It was user error.On (b)(6) 2023, the agent walked them through how to use the equipment with more thorough details than previously at the hospital.The issue was resolved.

• 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: 18920162
• MDR Text Key: 337847029
• Report Number: 3004209178-2024-07226
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/09/2024
• Date Device Manufactured: 12/12/2023
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG