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); Energy Output Problem (1431); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id m995402a001 lot# serial# (b)(6) implanted: explanted: product type 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: m995402a001, serial/lot #: (b)(6), ubd: , udi#: ; product id: 97745, serial/lot #: (b)(6), ubd: , 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.The reason for call was patient reported that they have been having problems with the controller for maybe as much as 6 months now.Patient clarified that the controller is unresponsive and there is no way to adjust the settings.Patient said that when the controller would turn on, it wants them to program it with the date and time, but it won't successfully move past the pairing screens.Patient also noted it would say looking for a device, but the controller would never recognize the implant.Patient mentioned that the controller would no longer charge at all.Agent had the patient remove the battery pack from the controller and connect the controller to the ac power supply.Patient confirmed that the screen turned on initially.Patient put the battery back into the controller, but the patient did not see a green solid or flashing light above the screen.The issue was not resolved through troubleshooting.A replacement controller and battery pack was sent out.

Manufacturer Narrative

Concomitant medical product: product id m995402a001, serial# (b)(6) product type product id 97745 serial# (b)(6) product type programmer, patient h3:analysis of the (b)(4) battery pack (bp) (serial number (b)(6)) revealed a no anomalies.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.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.

Event Description

Additional information received from the patient provided their weight at the time of the event.

• 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: 19055714
• MDR Text Key: 340002730
• Report Number: 3004209178-2024-08621
• 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: 05/10/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 95 KG