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

Model Number 977006

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

The patient called in saying he feels some sensitivity when he sleeps on the right side, he can feel the implant.He also thinks that the leads probably have gotten loose because he suddenly does not feel anything when he lays flat on his back.

Manufacturer Narrative

Concomitant medical products: product id 977a260 lot# serial# (b)(4), implanted: (b)(6) 2022, explanted: product type lead product id 977a260 lot# serial# (b)(4), implanted: (b)(6) 2022, explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2026, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2026, udi#: (b)(6) 2026.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

The patient (pt) reported they let their rep know that they are feeling more sore and feeling stimulation while swimming.The pt also reported they try and keep moving and not sit idle all day to help with their pain.Pt has an appointment with their hcp tomorrow and will review the questions sent to them in a letter before sending the response back.

Manufacturer Narrative

Continuation of d10: product id 977a260, serial# (b)(6), implanted: (b)(6) 2022, product type lead.Product id 977a260, serial# (b)(6), implanted: (b)(6) 2022, product type lead.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

Additional information was received from the patient.They called back stating they just received paper from the manufacturer.Pt went on to talk about how they got the message 201 already.Pt noted they had met with had two different technicians to reprogram the implantable neurostimulator (ins) for more battery life; it had been 10 months and reprogrammed twice, then they had it programmed to come on for 15 minutes then stay off for an hour.Pt noted they still took medications even thought they had the ins.When the ins worked it was great then the ins would wear out.Probably about 4 months of having it in their back was when the issues started then 7 months after having it they called to get it reprogrammed due to the usage.Pt noted they still had discomfort when they laid on the ins and when they toss in bed it would wake them up.Pt was redirected to their hcp.

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: 14886104
• MDR Text Key: 295130194
• Report Number: 3004209178-2022-08374
• 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,Followup,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2023
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 66 YR
• Patient Sex: Male