MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97702

Device Problems Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Dyspnea (1816); Insufficient Information (4580)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# unknown implanted: explanted: product type lead b3: date is approximate (month and year).G2.Foreign: netherlands 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was experiencing a sensation of pressure at their chest.The manufacturer representative (rep) received a question from a nurse regarding a patient who experiences a band feeling around the chest when they turn on their implanted neurostimulator (ins).This also makes the patient short of breath.Both an hd and a conventional program have been tried, but the patient experiences the same feeling with both programs.When they turn off the ins, the feeling immediately disappears.It was wondered if technical services (ts) had heard of something like this before and a possible cause for it.The patient¿s current lead was implanted in 2013, current ins implanted in 2020.Ts was unsure of the cause.To verify the issue (whether the lead may have moved/migrated), the patient¿s doctor may consider taking an x-ray.The issue has not resolved.Additional information was received.Healthcare provider information provided.The patient first started to experiencing chest tight ness/shortness around a year and a half ago, but it has gotten worse.It has progressed slowly since then.A manufacturer representative (rep) was made aware of the issue on 2023-dec-04.A ¿band feeling¿ was confirmed to mean the patient felt as if a band was being tightened around their thorax.The last ins change was in 2020.Nothing specific occurred causing this issue, the cause is currently unknown, and impedances were normal.None of the programs were changed when the bond feeling developed.Program has been changed in the meantime, but the band feeling was still retained with any form of therapy (hd and conventional).As of now the patient only sometimes feels the stimulation in the correct area, it can vary and depends on position.Ins confirmed to be placed in the left buttock region.The issue has not yet resolved.Logs will be obtained, but a date hasn¿t been set to do so.The information was confirmed with the physician/account.They have agreed with the patient that a control photo will be scheduled, and an appointment will be scheduled with the rep at the outpatient clinic for reprogramming.***merged from (b)(4).Duplicate file confirmed by the rep.2023-dec-14 mpxr 1128117, e1, e2 (rep, for): no new information.(the patient says that when the stim is on, it feels as if a band is tightened around the thorax, duplicate information)*** no new information.

Event Description

Additional information was received.It was confirmed that the appointment for the patient has been made for (b)(6) 2023.

Manufacturer Narrative

Foreign: netherlands 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

Additional information was received from a manufacturer representative (rep).It was reported that the cause of their symptoms was not determined.Reprogramming solved the problem.No logs were obtained.The provided information has been confirmed with the physician/account.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18348184
• MDR Text Key: 331081933
• Report Number: 2182207-2023-02800
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."