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

Model Number 97702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Discomfort (2330); Alteration in Body Temperature (4568); Swelling/ Edema (4577)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3487a-45, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Product id: 3888-56, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 3487a-45, serial/lot #: (b)(4), ubd: 07-oct-2023, udi#: (b)(4).Product id: 3888-56, serial/lot #: (b)(4), ubd: 19-feb-2018, udi#: (b)(4).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 patient presented with swelling tenderness and pain at the stimulator pocket and cranial facial lead sites. lead cut and left in patient to facilitate future channel/lead placement. surgery performed where it was determined an infection was present.Stimulator removed and existing fascial leads cut and left in place to provide future access for new leads. patient presented with tenderness, pain and swelling.Surgical procedure determined an infection was present.Stimulator removed as well as leads but not extensions.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3487a-45, lot# va2315n, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: lead.Product id: 3888-56, lot# va0ge5c, implanted: (b)(6) 2014, explanted: (b)(6) 2021, 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

Pt told reported to rep they had pulling and discomfort at the supraorbital lead and it was painful.Hcp explanted as pt is high infection risk and there may have been infection present so preferred not to re-implant system.No troubleshooting was reported; explanted due to possible infection, discomfort and lack of efficacy.

Manufacturer Narrative

Continuation of d10: product id 3487a-45 lot# va2315n, implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type lead product id 3888-56, lot# va0ge5c, implanted: (b)(6) 2014, explanted: (b)(6) 2021, 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 manufacturer representative (rep).Pt remaining leads were explanted.Case was (b)(6) 2022,medtronic wasn¿t present or needed.Md originally left leads to save the track so he could replace, but the infection wasn¿t healing so the md explanted the leads and no product remains.

Manufacturer Narrative

Continuation of d10: product id: 3487a-45, lot#: va2315n, implanted: 2021 (b)(6), explanted: 2021 (b)(6), product type: lead.Product id: 3888-56, lot#: va0ge5c, implanted: 2014 (b)(6), explanted: 2021 (b)(6), 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

The rep reported that the pt informed them they were going to original md who implanted facial scs several years back to re-implant quad plus leads into her right cheek facial area.All previous devices are explanted; ipg due to infection and leads due to possibly tracking.Or said md will work with infectious disease to make a plan for future re-implant of leads and ipg.Pt seeing original implant md.

Manufacturer Narrative

Continuation of d10: product id: 3487a-45, lot# va2315n, implanted: (b)(6) 2021, explanted: (b)(6)2021, product type: lead; product id: 3888-56, lot# va0ge5c, implanted: (b)(6) 2014, explanted: (b)(6) 2021, 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 (pt) on (b)(6) 2022 that their chest was swollen and hot to the touch where the ins was implanted.

• Brand Name: SURESCAN
• 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: 12377999
• MDR Text Key: 268487512
• Report Number: 3004209178-2021-13023
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Date Device Manufactured: 09/13/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female