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

Model Number 97712

Device Problems High impedance (1291); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problems Headache (1880); Visual Impairment (2138); Halo (2227); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Refer to regulatory report #(b)(4).The patient had two implanted systems and it was not clear which issues pertained to which implanted system.The referenced report pertains to the patient¿s other system.If information is provided in the future, a supplemental report will be issued.

Event Description

Manufacturer representative reported high impedances on 2 of pts leads, pt has 2 systems placed subclavicle.They are placed to control right side or left side.The 8-15 leads which are believed to be placed along the occipital nerve appear to have high impedances an multiple electrodes.Left electrodes 8,10, 14, 15 oor >10k.Right lead 8, 20, 11, 12, 13, 14 all oor >10k.Patient is a very active individual who likes to back pack and had inquired if the backpack straps and load may have caused the issue.Impedance check was conducted.Left lead removed the affected electrode from the programming.Right lead turned the effected lead programming off.Patient to follow up with hcp and rep in (b)(6).Issue was not resolved at the time of report.

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 form the patient and it was reported the reprogramming that occurred with a manufacturing representative (rep) did not resolve the issue.The malfunctioning leads have been turned off.The patient will be having surgery to repair those leads.

Event Description

Additional information was received.It was reported the device would be removed on (b)(6) 2020.It was noted the device would not be removed just relocated and the leads would be extended.

Manufacturer Narrative

Continuation of d10: product id: 977a275; lot#serial#: (b)(6); implanted: on (b)(6) 2014; product type: lead; product id: 977a275; lot#serial#: (b)(6); implanted: on (b)(6) 2014; product type: lead; product id: 977a275; lot#serial#: (b)(6); implanted: on (b)(6) 2014; product type: lead; product id: 977a275; lot#serial#: (b)(6); implanted: on (b)(6) 2014; product type: lead; product id: 97712; lot#serial#: (b)(6); implanted: on (b)(6) 2017; product type: implantable neurostimulator.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.

Event Description

The patient reported that the patient thought that there was something wrong with the system and that there could be a problem as the patient went to the hospital on (b)(6) 2020 due to problems with her vision.The patient has lead placed on her occipital lobe and she was seeing double vision, halos, and double of everything.The patient wanted to have the impedances checked.

Manufacturer Narrative

Continuation of d11: product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2014, explanted: product type lead product id 977a275 lot# serial# (b)(6) implanted: (b)(6) 2014, product type lead product id 977a275, serial# (b)(6) implanted: (b)(6) 2014, product type lead product id 977a275, serial# (b)(6) implanted: (b)(6) 2014, product type lead, product id 97712, serial# (b)(6), implanted: (b)(6) 2017, product type implantable neurostimulator.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

It was reported the device was relocated on (b)(6) 2020.

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.

Manufacturer Narrative

Continuation of d10: product id 37791 lot# serial# unknown implanted: explanted: product type recharger product id 37791 lot# serial# unknown implanted: explanted: product type recharger product id 977a275 lot# serial# (b)(6) implanted: 2014(b)(6) explanted: product type lead product id 977a275 lot# serial# (b)(6) implanted: 2014(b)(6)explanted: product type lead product id 977a275 lot# serial# (b)(6) implanted: 2014(b)(6) explanted: product type lead product id 977a275 lot# serial#(b)(6) implanted: 2014-(b)(6) explanted: product type lead product id 97712 lot# serial# (b)(6) implanted: 2017-(b)(6) explanted: product type implantable neurostimulator 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.The patient reiterated that she had both her implants moved from her chest to underneath her ribs.Pt stated that ever since she had the implants moved, she has had difficulty charging them.Pt stated that she had the left implant revised around thanksgiving and the right implant moved on 2020-(b)(6).Pt stated that she is unable to get any of the coupling boxes filled in and is unable to connect her programmer to her implant because the implants are depleted.Pt stated that after the first revision, she did not try and charge her implant because she still had stitches.Pt also mentioned that if one implant is turned off and the other is turned on, she gets a really bad headache.Pt stated that her very last charge was before her first surgery.When she charges her implants, she is able to get the coupling boxes at the bottom but none of them are shaded in.Two recharger antennas replacement was sent to the patient.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10727221
• MDR Text Key: 214818189
• Report Number: 3004209178-2020-18576
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR