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); Charging Problem (2892); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/18/2023

Event Type  Injury  

Event Description

Information was received from a manufacturer's representative (rep) regarding an external device.The reason for call was the caller indicated that they could not connect to the implant with the patient controller.During the appointment they tried using the patient controller and recharger.The caller indicated that they also tried using a second controller and recharger.The clinician tablet would not connect to the implantable neurostimulator (ins).The issue was not resolved through troubleshooting.The caller started the passive charging function and confirmed that they were able to get the numbers on the screen to change as the antenna was moved.The caller will continue charging with the patient.Additional information was received.Rep said it been 20 minutes of passive recharge but patient isn't getting the normal recharge screen.Ts recommend at least another 20 minutes of passive recharge and if device still won't give the normal recharge screen then rep is to disable and then re-enable implant.Passive recharge screen showed low of 95 and high of 100.Rep disabled device and was in passive recharge mode for a while, and ts had rep tried disable and re-enable again, but patient can only manage the passive recharge screen.Rep said the implant is not deep, and neurostimulator site looked fine.Ts agreed to replace the recharger and controller, even though rep used their own recharger and controller for this process.Additional information was received from a manufacturer representative (rep).It was reported that the stimulation system was explanted and returned for analysis.

Manufacturer Narrative

Continuation of d10: product id 97755 lot# serial# (b)(6); product type recharger product id 97745 lot# serial# (b)(6); product type programmer, patient product id 977a275 lot# serial# (b)(6); product type lead product id 977a275 lot# serial# (b)(6); product type lead product id 97791.Product type accessory product id 97791.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.

Manufacturer Narrative

Continuation of d10: product id 97755 serial# (b)(6) product type recharger product id 97745 serial# (b)(6) product type programmer, patient product id 977a275 serial# (b)(6) product type lead product id 977a275 serial# (b)(6) product type lead product id 97791 serial# unknown product type accessory product id 97791 serial# unknown product type accessory correction to h6: device codes omitted from pervious report.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: 19165884
• MDR Text Key: 340850952
• Report Number: 3004209178-2024-09609
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Date Manufacturer Received: 04/08/2024
• Date Device Manufactured: 11/29/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female