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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Failure to Power Up (1476); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was caller reported having issues with the controller and cannot charge the implant since around (b)(6).Caller said the controller only "stays on" when plugged into the ac power supply; pt can see no device found when plugged into ac power supply.Patient service specialist walked caller through removing the battery pack and plugging controller into the ac power supply; caller confirmed controller powers on.Caller confirmed no solid or blinking green light on the controller when battery pack was reinserted but pt still saw normal unlock screen.Green light on ac power supply was on.Pt tried a different outlet but still did not see a solid or blinking green light on the controller.Agent had pt disconnect from ac power supply and controller went blank and unresponsive; controller was also unresponsive when recharger was plugged in.Caller denied any visible damage to the recharger, battery pack, and controller battery pack compartment.Agent reviewed to fully charge replacement controller and call back if necessary for further troubleshooting.The issue was not resolved.An email was sent to the repair department to replace the ac power supply, controller, and battery pack.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6) , ubd: , udi#: (b)(4)h3:analysis of the 97745 controller (ptm) (serial number (b)(6) ) revealed a cracked/broken/worn back case.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: 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: 19032612
• MDR Text Key: 339246811
• Report Number: 3004209178-2024-08357
• 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: 05/17/2024

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: 08/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 65 KG