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

Model Number 97715

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755-s lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the 97755 recharger (rtm) (s/n#:(b)(6) revealed that it could not power on a controller.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

It was reported that information was received from a patient (pt) regarding an external device.The reason for call was patient reported that the implanted neurostimulator (ins) was not charging.Patient said the battery had been dead and they had been trying to charge it up, but the controller would not acknowledge that the recharger was plugged in.Patient service specialist had patient reset controller by making sure nothing was plugged into the controller, remove the battery pack, plugging controller into the ac power supply, patient confirmed controller powered on.Patient then reinserted battery pack and confirmed green light on controller was flashing.Patient plugged recharger into controller and the controller did not respond; controller was registering ac power and li battery, but not recharger.Patient unplugged recharger and inspected controller port and recharger plug, and said it looked fine.Patient was in a lot of pain as they were not able to charge the implant.The issue was not resolved.An email was sent to the repair department to replace the recharger.  pt called back stating that they still hadn't received the replacement recharger and that they were in a so much pain that they couldn't do anything.Pt noted that they didn't have pain medications so they relied on the ins.Agent reviewed the tracking information with the pt; according to fedex there was a delay while in transit, but the delivery was expected today by 10:30 am.Agent provided the pt with the fedex tracking number and fedex's customer service phone number for possible further assistance if needed.Agent apologized to the pt for the delay with fedex.

Manufacturer Narrative

Continuation of d10: product id 97755-s lot# serial# (b)(6).Product type recharger 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: 18980654
• MDR Text Key: 338683332
• Report Number: 3004209178-2024-07852
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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: 05/23/2024

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: 08/14/2023
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 82 KG