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

Model Number 97716

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Operating System Becomes Nonfunctional (2996); Insufficient Information (3190)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was yesterday the pts controller was no longer working, they could not get the controller to turn on or off or anything.They could not control the device.The controller was blank and would not turn on or anything.The pt normally had it at high until they take their medicine at night (agent understood they had their intensity turned at high).The pt went to turn it down last night and it would not come on even though the controller was at 90% charged last night.During call pt did not have their ac power supply with them.They put two aa batteries into the controller and the controller turned on.Pt put the black battery back into the controller and the controller did not turn on.Agent reviewed with pt to try and charge the controller with the battery back in to see if it turned back on.Pt noted that the holder for the controller was missing.An email was sent to the repair department to order a intellis controller carrying case.  pt called back stating their controller was plugged in for 3 hours and is still not charging.Agent had pt reset controller and plug controller into ac power supply with the battery pack removed.Pt confirmed screen did appear.Pt then inserted battery pack but there was no blinking green light on the controller.Pt saw controller with a plug symbol and implant at 90%.Agent sent email to repair to replace the battery pack.

Manufacturer Narrative

Continuation of d10: product id 97745nt serial (b)(6) : product type section d information references the main component of the system.Other relevant device(s) are: product id: 97745nt, serial (b)(6) : medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18812953
• MDR Text Key: 336990794
• Report Number: 3004209178-2024-06046
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 11/07/2022
• 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
• Treatment: "SEE H11...."
• Patient Age: 63 YR
• Patient Sex: Female