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); Electromagnetic Compatibility Problem (2927)

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

Event Date 03/21/2024

Event Type  Injury  

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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that today they had a cardioversion procedure with their heart.Patient stated that they turned their implanted neurostimulator off for the procedure and put into mri mode.Patient said that they then went home and tried to turn their therapy back on and saw a message that said to contact medtronic code 323.Patient service specialist redirected patient to healthcare provider to further address service code 323 and check the implant.Additional information was received from the manufacturer representative (rep).It was reported that rep is seeing patient today following a cardioversion about 3 weeks ago and patient is not able to communicate with ins.Caller reported patient programmer shows service code 323.Agent reviewed meaning of code.Caller is seeing unexpected error 0x61e4156b and content around turning amp/pulse width/etc.Lower.Caller restarted tablet and tried a second tablet and not able to get past this message.Patient did not contact anyone from manufacturer prior to the cardioversion and just turned mri mode on for the procedure.Caller will find out who did the cardioversion as a contact.

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.

Event Description

Additional information was received, from the manufacturer representative (rep).It was reported, that rep is seeing patient today.Following a cardioversion about 3 weeks ago.And patient is not able to communicate with ins.Caller reported, patient programmer shows service code 323.Agent reviewed meaning of code.Caller is seeing unexpected error 0x61e4156b and content around turning amp/pulse width/etc., lower.Caller restarted tablet and tried a second tablet and not able to get past this message.Patient did not contact anyone from manufacturer, prior to the cardioversion and just turned mri mode on for the procedure.Caller will find out who did the cardioversion as a contact.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that patient put device in mri mode before procedure this was patients first cardio version.They do not have a report from a successful interrogation.It was the first time they met the patient.Patient's ins was replaced to resolve communication issues.Patient's issues are resolved.Patient discarded ins.

Manufacturer Narrative

Continuation of d10: product id a71200 serial# unknown product type software.Product id a72200 serial# unknown product type software 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: 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: 19112237
• MDR Text Key: 340257524
• Report Number: 3004209178-2024-09122
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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 Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/13/2024
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male