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

Model Number 97715

Device Problem Failure to Power Up (1476)

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

Event Date 03/08/2022

Event Type  malfunction  

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

Information was received from a patient regarding an external device. it was reported that they were having issues with their controller and the issue began 2 years ago.Patient stated they had to have an mri of their back because their back my have herniated.Pt mentioned they had leg pain as well.Patient said their friend had the exact same equipment and they were able to charge the implant with the other persons equipment.Pt stated that even though the implant was charged they were unable to find the device with their controller.Pt also made mention that 2 years ago it "died" or stopped working.Patient was able to charge their implanted device for the mri, but could not get the controller to work to go into mri mode.Patient did not have the recharger with them and patient service specialist was unable to collect recharger serial number.The issue was not resolved.An email was sent to the repair department to replace the controller.Patient provided an updated address.2024-mar-11 rtg0555293 (con, rep): additional information received.Patient rep called in because patient just received replacement controller, but now the controller will not turn on once the current battery pack was inserted.Patient rep tried plugging controller into the wall, and the controller was still unresponsive with no flashing green light above the controller screen.Agent had patient rep remove the battery pack and plug the controller into ac power supply without the battery pack, and screen turned on.Once battery pack was reinserted, there was still no flashing green light.Patient rep is also a medtronic intellis patient, so patient rep put their battery pack into patients controller, and the controller started charging as normally.An email was sent to repair to replace the li battery pack.Patient rep mentioned that the patient has an mri tomorrow, and an appointment with a surgeon on wednesday, and asked if patient reps battery pack could be used in patients controller in the mean time to charge the implant and go in and out of mri mode.Agent reviewed information regarding battery pack interchangeability.Agent reviewed aa battery usage as well.Pat ient called back requesting tracking information.Agent reviewed fedex tracking information and estimated delivery.Patient commented that they have to have it today.

• 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: 18988515
• MDR Text Key: 338750411
• Report Number: 3004209178-2024-07935
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Date Device Manufactured: 10/24/2018
• 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
• Patient Age: 62 YR
• Patient Sex: Female