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

Model Number 97800

Device Problems Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)

Patient Problem Incontinence (1928)

Event Date 03/08/2024

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 since implant on (b)(6) 2023 and it helped by 50% or greater for their leakage but then on (b)(6) 2024, the patient had a total hip replacement and ever since the hip surgery, the patient didn't think it was working for their symptoms, because they were wet all the time and they would leak constantly, especially at night and if they stood up, they would gush.Patient stated that prior to the hip surgery, the orthopedic surgeon consulted with their urologist to make sure the surgery was successful.The patient stated they had a health care provider (hcp) appointment today however their hcp had told them if they needed assistance with their ins or therapy settings they should call "tech support." patient services reviewed the role of patient services and the health care provider (hcp) with the patient and provided the patient with the national answering services (nas) number for the hcp to page a medtronic representative if needed to check the patient's implanted system.Patient services r edirected the patient to follow up with the health care provider (hcp) to check the implanted system and reviewed programming considerations with the patient.The patient stated they would follow up with their health care provider (hcp) but wanted to try to make an increase to their stimulation with patient services in the meantime.The patient was already connected to their settings and the therapy was on.The patient then increased the stimulation to a comfortable level where the patient felt it in their bike-seat region.The patient was going to monitor their symptoms now that a change had been made and follow up with their health care provider (hcp) later today.They stated they may switch to another program if the increase did not help but noted they would monitor their symptoms in the meantime and give their body the chance to respond to the therapy increase first.Additional information was received from a healthcare professional (hcp).The hcp reported that the issue has not yet been resolved.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• 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: 19126923
• MDR Text Key: 340405944
• Report Number: 3004209178-2024-09260
• 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: 05/09/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/09/2024
• Date Device Manufactured: 07/14/2023
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 88 KG