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)

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

Event Date 03/15/2024

Event Type  Injury  

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurost imulator (ins).The reason for call was the rel.Called and said they just were in a case with a pt who had a new lead placed today to add a second percutaneous lead.Rep said they connected to the ins just fine prior to the case with their tablet and the ins was able to be interrogated successfully.During the case, the ins was taken out of the pocket and the pt tried to connect with the ins, but the tablet progressed to 100 percent in the communication in progress screen, and the "select the device" screen showed the pt's serial number for their ins, but after reaching 100, the tablet displayed no device response.Rep tried connecting the communicator cord to the communicator and the tablet and tried resetting the intellis app, but issue remained.Rep.Tried using another communicator and tablet, but issue remained.Rep.Said they tried to connect the communicator to another new ins, and the tablet and communicator connected without issue to the other new ins.Rep.Tried ens and ens connected successfully without issue to leads.Hcp made the decision to end the procedure and close the pt.Then, post op, rep.Tried to connect to the ins with the tablet with the commun icator cord connected, but got same issue.Mdt rep.Called ts.Technical services (ts) had the rep.Use the other tablet and communicator, but the tablet located pt's ins went to 100 percent, then said no device response.Both tablets and communicators were tried with same result.Mdt rep.Then clicked allow in the pt data services app and got same result.Mdt rep.Said the pt was in bed in a recovery room and did not report any detectable signs of emi.Mdt rep.Connected the pt's controller to the ins successfully and maintained wireless connection.Ins charge was 80%.Controller charge was 80%.Ins was disabled and re-enabled in tech mode.When the rep engaged the charging session of the ins, poor recharge quality displayed.Mdt rep.Pressed cancel, locked the controller, and placed the controller across the room.Mdt rep.Then tried to interrogate the ins again,but communication in progress screen went to 100, followed by no device response, followed by searching for communicator.It was noted that the ins went dead and could no loner be communicated with.Correct serial number confirmed in the "select the device" workflow prior the the communication in progress screen.Tss discussed possible steps forward with mdt rep.  patient's physician has decided to explant their ins to replace it, as it was working prior to surgery and then lost connection during surgery and has not connected since.Rep is requesting documentation of the troubleshooting that was completed on the previous call for insurance.No symptoms were reported the patient recovered without sequela.

Manufacturer Narrative

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: 19082089
• MDR Text Key: 339877811
• Report Number: 3004209178-2024-08835
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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: 01/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female