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); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Pain (1994); Distress (2329)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial# (b)(4), product type: programmer, patient.Product id: 97755, serial# (b)(4), product type: recharger.Product id: m995402a001, serial# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt states they were having problems with controller.Taking long time to charge battery and just plugs in and says no device found or change battery and just keeps saying same thing over and over.Advised to reset, pt states they had done this already.The issue was not resolved through troubleshooting. pt called back stating "its not working" and that they were in pain.Pt confirmed they haven't received the replacement yet.Agent advised to wait for the recharger to arrive and see if that resolves the pt's issues. pt was very frustrated because they had already called 4 times and they didn't get someone who spoke spanish.Pt said that they received their rtm replacement, but they were not able to charge their implant.Pt said that they spoke with a medtronic rep the day before yesterday and again yesterday regarding the issue and they said the issue could be the battery pack.Pt was very frustrated and didn't want to troubleshoot the issue on the call; pt said they were in pain.Pt mentioned that their controller battery stayed at 80%-70% since yesterday at 2 pm.Pt said they kept seeing "reposition" and "try again" when trying to charge their implant.Pt then said a screen saying to insert medtronic battery would come up.Pt agreed to troubleshoot the issue toward the end of the call and started a charging session with their implant; pt said that the screen "recharging not available cannot continue.Install medtronic battery pack and try again" (78) appeared on their controller after trying to get connected to charge their implant.Pt said they had the li battery pack inserted, not aa batteries.Consulted with repair and repair suggested sending controller and battery pack replacement.

• 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
• MDR Report Key: 12724355
• MDR Text Key: 282111336
• Report Number: 3004209178-2021-16160
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR