MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97715

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755 ,serial# (b)(6), product type recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6), udi#: (b)(4).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

Information was received from a patient regarding an external device. it was reported that they hadn't been able to charge the implanted neurostimulator for the last two days.Patient stated that the controller would be at 100% and they would have a great connection, however after a couple minutes the recharger needs attention screen would come up when they hadn't even moved.Pt said that the device wouldn't turn back on then and resetting the controller did not resolve.Pt said that they talked to a rep who said that the battery wasn't holding a charge.Agent had the pt remove the battery pack from the controller and connect the controller to the ac power supply; pt confirmed that the controller powered on.Agent then had the pt reinsert the battery pack into the controller while the controller was still connected to the ac power supply; pt confirmed seeing the controller light flashing green. agent had the pt unlock the controller; pt saw the batteries screen with the controller battery at 90% and the ins battery at 50%.Pt saw that on the recharger cord there was a color difference where the cord connected to the paddle; pt noted that it wasn't even a 1/4 inch.Agent had the pt initiate an ins recharging session; pt saw no device found appear.Pt went into passive recharge mode with the middle number as 96, however the controller light was not flashing green and no device found appeared again.Pt said that they had been having a lot of trouble getting the equipment to connect to the ins lately and that they had lost a lot of weight so they thought that the ins may have moved from losing weight.The issue was not resolved.An email was sent to the repair department to replace the recharger.Patient provided an updated address; patient service agent sent an e-mail to prs for update.Pt mentioned during the call that their nails were too long and that their nails would break when removing the battery pack from the controller.When asked for the event date, pt said that they were sick for a while so they didn't know, but the message appearing when trying to recharge the ins had been off and on for like two weeks.

Manufacturer Narrative

Continuation of d10: product id 97755, serial# (b)(6), product type recharger product id 97755, serial# (b)(6), product type recharger h3: analysis of the recharger found device got a no device found message.No anomalies were visually observed.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: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 18965636
• MDR Text Key: 338556968
• Report Number: 3004209178-2024-07698
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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: 05/29/2024

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: 10/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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 Sex: Female