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

Model Number 97800

Device Problems Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/25/2024

Event Type  malfunction  

Event Description

(b)(6) 2024 information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that their device was working better than 70% , they could sleep through the night, prior to their fall onto their ins side at the end of january.They spent the entire month of february in rehab and now it's all messed up, not helping.The fall did not cause any broken bones, but there's a lot of inflammation to the nerves and now there's a dull pain right where the implant site is, they were still in a lot of pain, but the pain is better now than it was.While they were there they called the manufacturing representative (rep) who came to the rehab center and checked their ins and said everything was fine and bumped it up, but that increase did not help.They are trying to in touch with the rep and left them messages.The patient didn't want to make any adjustments, but said that stating yesterday (2024-mar-17) they had increased from 4.9 to 5.3 and that did not help, but they will give it a chance and will wait for the rep to call back.Redirect to doctor if issue persists.On 2024-mar-21 additional information was received from a healthcare professional (hcp).The hcp reported that the fall's effect on the device was not determined.The patient was seen by the rep on 2024-jan-16 and the device was adjusted.It is unknown if the issue was resolved.On 2024-mar-29 additional information was received from a manufacturer representative (rep).The rep reported that they were made aware around (b)(6) 2024 that the patient had needed someone to reach out to them due to the fall.They reached out to the patients' doctor, b ut they didn't have any further details, so on 2024-feb-06, the rep reached out to the patient.The patient stated that they had fallen the end of (b)(6) 2024 and ended up with 3 different er visits and they were currently in a patient rehab facility.The rep was able to visit with the patient to perform an impedance check and to make sure the device was working properly.On 2024-feb-06 impedance was found to be within normal limits.The device was on configuration 4 at 4.8 with appropriate sensation.The patient was planning to schedule a follow up appointment with their doctor after they were released from rehab.As on (b)(6) 2024 the patient has not had a follow up visit.

Manufacturer Narrative

B3: event date is estimated.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: 19002289
• MDR Text Key: 339290101
• Report Number: 3004209178-2024-08080
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 04/21/2022
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 63 KG