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); Overheating of Device (1437); Delayed Charge Time (2586); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Operating System Becomes Nonfunctional (2996)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 97755, serial# (b)(6), product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(6) , udi#:(b)(4), b3: date is approximate h3: analysis of the recharger (product id 97755, serial# (b)(6), found no anomalies.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient (pt) said they could not get their ins to recharge.Pt said they could get it on good, then to excellent however, if they moved an inch, it would turn off and go to checking recharge quality and one time turned completely off.Pt said they had to lay across the bed and not move for a long time just to get the ins to recharge.Pt notices the recharger (rtm) getting warm while recharging but not hot.The patient was sent out a replacement recharger (rtm).No symptoms were reported.  the patient (pt) called back stating they were attempting to recharge their implant and their controller became unresponsive.Patient services (pss) walked pt through a reset and reviewed that pt should wait to charge their replacement. additional information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). pt called back for assistance with pairing the controller to their ins as they were seeing the setup screens.Patient services (pss) began walking the pt through the pairing process, however pt stated that the controller wasn't charged.Pt confirmed that they had the controller connected to the ac power supply and that the green light was flashing above the screen.Patient services (pss) advised the pt to allow the controller to fully charge and that when the green light turned solid to call pss back for further assistance. pt called back with controller charged and ready to pair.Pss was able to walk the pt through pairing the controller to the ins successfully.Pss was walking the pt through recharging the ins; however, no device found' kept appearing.Pss reviewed recharger (rtm) placement over the ins with the pt.Pt noted that they had the rtm paddle placed over their pajama bottoms.Pss suggested that the pt use the belt.After several attempts pt had assistance from a member in hou sehold to try and recharge the ins.Pt was unable to successfully get a connection between equipment and ins.Patient services (pss) redirected pt to their healthcare provider (hcp)and / or manufacturer representative (rep) for further assistance as replacing equipment did not resolve the issue.Pt stated during the call that they were in so much pain since they had been standing too long.Pt stated that the rtm cord wasn't long enough when trying to place rtm paddle in the belt and arrange equipment over ins site; pt then had assistance from their household member in arranging equipment over ins.Pt stated that before when they would move the rtm paddle just a dog's hair, the connection would change; pt stated that they were using the belt when this happened.Caller confirmed that they ins site looked like it was healing properly.Caller kept attempting to reposition rtm over ins site and recharge ins, however poor recharge quality kept appearing.Caller stated that the ins was last charged three days ago.Caller kept attempting to reposition rtm over ins site and recharge ins, however poor recharge quality kept appearing.Caller stated that the ins was last charged three days ago.Pss reviewed that any possible swelling in the ins site would cause for a poor connection between the equipment and ins.Additional information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).After the patient was redirected to their healthcare provider (hcp), they determined that their implant sticks out so they can't get a good connection.It takes them two hours to charge the implant about every 24-36 hours.The pt stated that their healthcare provider (hcp) will make a decision when they see them on april 4th.They are so frustrated with the whole situation, it takes 2.5-4 hours to charge the implant and if they move the slightest during this time they lose connection.

• 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: 18956186
• MDR Text Key: 339242540
• Report Number: 3004209178-2024-07582
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• 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: 79 YR
• Patient Sex: Female