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); Overheating of Device (1437); Failure to Power Up (1476); Delayed Charge Time (2586); Battery Problem (2885)

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

Event Date 07/17/2020

Event Type  malfunction  

Event Description

Information was received from a friend/family member regarding a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that last night ((b)(6) 2021) when the pt was charging their ins at "excellent" charging quality, the controller screen went blank after 5-10 mins and the controller would not power back on.Caller mentioned that they charged the controller a couple of days ago; caller said that the controller was charged to 90% and the implant had no charge.Caller said that the pt has been experiencing longer ins charging sessions (caller mentioned that the pt had been complaining about this all along; it was understood that this issue has been since date of implant).The caller reset the controller.Caller said that there was no visible damag e to the controller, battery pack, or recharger (rtm).Caller confirmed that the controller powered on.Caller also confirmed that the rtm was not getting hot, just warm while charging the ins.The issue was not resolved.An email was sent to the repair department to replace the rtm.No symptoms were reported.

Manufacturer Narrative

Continuation of d10: product id: 97755, serial# (b)(6), and product type: recharger.Section d information references the main component of the system.Other relevant device(s) are: product id: 97755, and serial/lot #: (b)(6).H3.Analysis was performed on [product id: 97755, serial/lot #: (b)(6)] analysis found that the complaint was unverified.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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: 18796549
• MDR Text Key: 337623388
• Report Number: 3004209178-2024-05874
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1535-2021
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female