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

Model Number 977006

Device Problems Break (1069); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problems Scar Tissue (2060); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Information was received from a manufacturer's representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was rep called and reported that they were notified about 3 weeks ago that the patient's (pt) 977a2 leads from 2022 had not been advanced to the desired location due to old scar tissue, and that the pt was not receiving good coverage and the hcp had decided to do a lead revision to place a surgical lead.Troubleshooting was not required.The troubleshooting steps that were taken on the call resolved the issue.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2022 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2022 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 04-aug-2025, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(6), ubd: 11-jan-2026, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer's representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was rep called and reported that they were notified about 3 weeks ago that the patient's (pt) 977a2 leads from 2022 had not been advanced to the desired location due to old scar tissue, and that the pt was not receiving good coverage and the hcp had decided to do a lead revision to place a surgical lead.Troubleshooting was not required.The troubleshooting steps that were taken on the call resolved the issue.On 2023-jul-19 the rep reported the initial reported was patient's hcp.Weight was reported.

Manufacturer Narrative

Correction to mdr 3004209178-2023-13013: statement not included previously in b5: on 2023-jul-19 the rep reported the initial reporter was patient's hcp.Weight was reported.Statement added.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer's representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was rep called and reported that during lead revision case, the hcp was unable to retrieve all of a lead attempting to be removed.Rep reported that a lead fragment was left as abandoned and the new lead was placed.Troubleshooting was not required.Technical services (tss) reviewed mri compatibility.  on (b)(6) 2023 the rep reported hcp was performing a revision replacing perc leads with a paddle.They had a discussion before surgical case about the removal of the leads and how it was advised to remove anchors as well.The doctor decided to not remove anchors.Hcp removed the battery first and then did a laminectomy to free up scarred down proximal lead ends.Once hcp was satisfied with the freeing up of the leads, he went back to the distal end (the end that plugs into battery) and pulled with force.The first lead came out pretty freely, but the second lead proved to be more difficult.With a little extra force, the lead broke leaving a fragmented part of the lead.Rep informed the physician that leaving the fragment in patient would render patient ineligible for full body mri.Hcp understood the consequence and continued with procedure.

Event Description

Caller noted mri showed ineligible and confirmed caller had noted lead fragment in this previous call.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17364800
• MDR Text Key: 319482545
• Report Number: 3004209178-2023-13013
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2024

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: 11/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 07/18/2023; 01/23/2024
• Supplement Dates FDA Received: 07/20/2023; 08/16/2023; 02/12/2024
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 86 KG