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

Model Number 97716

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

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

Event Type  malfunction  

Manufacturer Narrative

G2: thailand 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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had a stroke 3 days after implant surgery, so the ins was not turned on and charged.Today ((b)(6) 2024) the patient came to the pain center for a consult with the doctor for re-programming.The manufacturer representative (rep) tried to interrogate the ins with the clinical tablet but cannot find the ins.When charging the ins with the controller, the screen of the controller showed ¿position the recharge over the implanted neurostimulator so that the highest number is show in the bottom center of screen¿; the numbers fluctuated in the 60s.The rep solved the problem according to the manual but the screen came back the same way more than 10 times in 30 minutes; having difficulties in charging the ins.Technical services reported that from the video of the issue, the recharger is behaving as expected. once they click on the recharge button, as the rep did, the recharger shows first the numbers to find the best location for charging (screen 50).After a while the recharger tries to communicate with the ins (screen 51).If the ins is sufficiently recharged to start a communication session, then the recharger will pass to a ¿normal¿ recharge mode. if no telemetry can be established, because the ins is still discharged, then the recharger goes back to the screen with numbers.Additional information was received from the manufacturer representative (rep) reporting that the reason of not being able to communicate was due to the ins battery being empty.Since implant surgery, the patient has never charged the battery or turned the device on until now.Troubleshooting was performed but did not solve the problem, the ins cannot be used.The patient would contact the hospital to discuss an ins replacement claim because the battery is guaranteed for 5 years.

• 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: 19042567
• MDR Text Key: 340117955
• Report Number: 3004209178-2024-08485
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2024

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 Model Number: 97716
• Device Catalogue Number: 97716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2024
• Initial Date FDA Received: 04/04/2024
• Date Device Manufactured: 07/19/2023
• 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