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

Model Number 977006

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id tm91scs lot# serial# (b)(6) implanted: explanted: product type product id tm91scs lot# serial# (b)(6) implanted: explanted: 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

Information was received from a patient regarding an external device.It was reported that the patient was not able to connect their communicator to their implanted neurostimulator.Patient had been on the phone with their manufacturer representative (rep) for an hour and they were unable to connect.Patient noted that they had 2 replacement shoulders and their arms did not go behind their back very well.During call patient reset the communicator and even disconnected the communicator from the handset but they could not connect to the ins.The blue light would only come on the communicator if they pressed the power button but once they released the power button the blue light went away.The issue was not resolved through troubleshooting.A replacement communicator was sent out.No symptoms were reported.  additional information was received from a patient (pt).It was reported that they received the new communicator and charged it up and need help to pair with the handset.During call, pt reset equipment and started pairing process, handset kept looking for communicator, communicator flashed blue once and gave only solid green light.After couple minutes, agent walked pt through resetting equipment, but same issue happened again.After 6 min of waiting, the handset still looked for communicator while communicator gave solid green color with no bluetooth indication. a replacement communicator was sent out.No symptoms were reported.  additional information was received from a patient (pt).It was reported that they received the replacement communicator but that they are still having the same issues.Patient stated that this their third communicator that they have tried and they are still unable to connect.Patient noted that they think there is a bigger issue going on besides the equipment.Agent attempted to walk the patient through pairing the communicator with their implant; patient stated that the handset screen would not advance past the connect screen.Patient noted that the communicator light was solid green and not changing.Agent advised that the patient should follow up with their doctor and mdt rep to have their implant looked at.Agent redirected the patient to their managing healthcare provider (hcp).

• 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: 19058215
• MDR Text Key: 340230628
• Report Number: 3004209178-2024-08628
• 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: 04/08/2024

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: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/08/2024
• Date Device Manufactured: 12/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male