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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the therapy wasn't working as well and they had to change the program a couple times.Patient services asked the patient when the issue began and the patient stated that when it got really cold they would start having problems where it wasn't letting them know earlier.The patient then stated they also had a really bad fall a couple months after they got the implant and that was when they started having problems with the therapy.The patient stated they spoke to their managing health care provider (hcp) about it at the time and the hcp told them that the lead had moved "a little bit" and said however "i think everything is fine" but to reach out if they started having "trouble." the patient stated they hadn't seen their managing health care provider since they moved to a new area and that they had found a new healthcare provider now they hadn't seen yet, butthey were going to make an appointment with that healthcare provider to discuss the issues they were having and to check the therapy settings.Patient services was reviewing the impact that a fall could have on the system and described patient activity compatibility considerations and mentioned no repetitive bending/twisting stretching and that was when the patient thought to say that ever since they moved to their apartment a year ago, every time they used the steps and lifted their legs, they would feel a "big tug" sensation close to their vulva.The tugging sensation was why they reached out to their hcp in the first place.The patient stated they would be moving out of that apartment shortly.Patient services reviewed programming and stimulation considerations and also reviewed positional stimulation but stressed the stimulation should only ever be comfortable for the patient and redirected the patient to follow up with their health care provider (hcp) to check the implanted system and discuss programming considerations.The patient's initial reason for call had been to inquire about mris and mri mode.Patient services walked the patient through connecting to their settings and activating mri mode.Patient noted they were mri conditional full body scan eligible but noted that where it said "patient name" it said "no name." patient services redirected the patient to follow up with their health care provider (hcp) to correct the mri mode information to dis play their name.Patient also mentioned they had never gotten an id card sent to them however they had just spoke with device registration yesterday and they were told they would be sent an id card.

Manufacturer Narrative

Continuation of d10: product id: 978b1, lot# unknown and product type: lead.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 who was implanted with an implantable neurostimulator (ins) for urgency frequency and urge incontinence.They reported that the issue was resolved by restarting the phone and changing programs.It was reported that the issue was resolved.

Manufacturer Narrative

Continuation of d10: product id 978b1; lot# nmg426209; product type lead; product id a52300; ser ial# unknown; product type software.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: 19019389
• MDR Text Key: 339109797
• Report Number: 3004209178-2024-08266
• 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: 05/14/2024

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 Expiration Date: 04/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/14/2024
• Date Device Manufactured: 10/18/2022
• 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
• Treatment: "SEE H11...."
• Patient Age: 55 YR
• Patient Weight: 122 KG