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

Model Number 977006

Device Problems Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id hh9020scs : product type product id tm91scs serial (b)(6) : product type 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

It was reported that information was received from a patient regarding an implantable neurostimulator.The reason for call was patient stated they need assistance unlocking their handset.Patient stated they don't remember the handset needing or having a password.Patient said they can't get the handset to open.Patient reported that they need to have an ekg done and so they are trying to use their handset.Troubleshooting was not required.Agent had to call healthcare it for further assistance with the handset; healthcare it stated that they could not assist and that the agent would have to replace the handset.The issue was not resolved through troubleshooting.The call got disconnected before agent could review information with the patient.Agent attempted to call patient back but patients voicemail was not set up so agent could not leave a voicemail.Pt called back, and restated the issue.Emailed repair to send replacement handset pt called back and mentioned they got the handset, but now they could not get the handset to connect to the communicator.Pt said the stimulator was in overdrive when the hcp performed the ekg, but upon clarifying, the pt confirmed the ekg results were skewed from the stimulator therapy.During call, communicator battery and bluetooth light were alternating back and forth.Communicator reset was attempted and handset was reset.Communicator was unplugged from ac power supply and handset was shut off.Lights on communicator went off when unplugged from ac power supply and both handset and communicator remained off for several minutes, but after turning handset and communicator back on, lights on communicator still alternated.Resets did not resolve issue.An email was sent to the repair department to replace the communicator.Upon further review, pt said because of the device issues, pt had been unable to turn off their ins therapy to get ekg.Agent reopened and reassigned case to add serialnumber of replacement communicator into secure note.Patient called back to inquire if they correctly paired the communicator and the handset.Patient was reading information when the therapy app then agent couldn't hear the patient respond.Agent attempted to call back but since voicemail was not set up agent couldn't leave a voicemail.Agent closed case.Pt called back and said they successfully paired the new controller.They wanted help using controller and were in mri mode.Pt mentioned that they had an ekg reading skewed as reported in previous call.During the call they successfully exited mri mode and said they wanted to leave it off so they can have an ekg.Reviewed controller usage with pt.Pt called back stating they had been trying to return the communicator and handset that were broken but had a difficult time calling fedex.Agent reviewed return options.

• Brand Name: VANTA
• 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: 18959762
• MDR Text Key: 338758380
• Report Number: 3004209178-2024-07637
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Sex: Female