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

Model Number 97800

Device Problem Failure to Deliver Energy (1211)

Patient Problems Incontinence (1928); Memory Loss/Impairment (1958); Confusion/ Disorientation (2553); Urinary Incontinence (4572); Insufficient Information (4580)

Event Type  malfunction  

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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the caller wanted assistance getting in touch with a medtronic rep to help the patient with any adjustments/guidelines on the therapy and said patient lost rep's number.Patient rep said that the patient is not feeling any stimulation.Patient rep said when they changed the program, they increased stim until the patient felt something and then the sensation went away.Patient rep said that it is hard to tell if the patient is receiving 50% or greater reduction in symptoms, it seems like it is working better than before the implant but sometimes the patient says they're wet and sometimes they're not.Patient rep said the patient wears diapers and it depends how much soda/coffee the patient drinks and if they have any at night, they said "good luck" (in terms of patient experiencing symptoms overnight).Patient rep said they don't monitor patient's symptoms constantly but can tell when they do laundry that the patient has had accidents.Patient rep said they know they've had accidents when the laundry smells like urine because patient's urine has a strong odor.Patient rep said they're worried about patient's nighttime symptoms most.Patient rep said they don't see a consistent pattern in symptoms/symptom relief.Patient rep said the patient has memory issues so the patient sometimes gets confused when asked about symptoms each day.When asked for event date, patient rep said they've had these issues even before the implanted device and they thought that getting the implant would help (they did not specify a date).Patient rep said if they didn't have issues a year ago, they might not have "walked down this road" (receiving implant).Troubleshooting offered to help with adjustments or questions over the phone and caller declined.Patient rep inquired about how/what they should monitor as far as symptoms and when they should be changing programs.Agent reviewed stimulation sensation vs therapy relief and reviewed basic therapy expectations.Emailed field staff.Patient rep said the patient is seeing managing hcp on friday.

• 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: 16264407
• MDR Text Key: 309131505
• Report Number: 3004209178-2023-01261
• 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: Other
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/30/2023
• Date Device Manufactured: 03/23/2022
• 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 Sex: Male