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

Model Number 97713

Device Problems High impedance (1291); Energy Output Problem (1431); Low impedance (2285); Malposition of Device (2616); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 39565-30 lot# (b)(6) serial# implanted: (b)(6) 2015 explanted: (b)(6) 2023 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(6), ubd: 03-mar-2019, 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 multiple sources (healthcare provider, clinical study, manufacturer representative) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that there was dysfunctional stim which did not relieve the patient.The patient only felt the stimulation in his right leg, and that if he increased the stimulation it was no longer tolerated. device interrogation occurred. there were poor (incoherent/wrong) impedances on all plots except 8 and 9.Meanwhile the patient stated he was satisfied by the stimulation.Device system explant occurred with in patient hospitalization.Outcome was reported as ongoing.Etiology was probably related to the implant procedure, not related to device or therapy.

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 the clinical site.It was reported that they thought the electrode was too low and too far to the right.Impedance results using electrode eight as the reference electrode were provided: electrode zero: 2819 ohms, electrode one: 6677 ohms, electrode two: 5282 ohms, electrode three: 663 ohms, electrode four: >10000 ohms, electrode five: 793 ohms, electrode six: >10000 ohms, electrode seven: 2773, electrode eight: reference, electrode nine: <(> <<)>50 ohms, electrode ten: 886 ohms, electrode 11: 8093 ohms, electrode 12: >10000, electrode 13: 593 ohms, electrode 14: 547 ohms, electrode 15: >10000 ohms.Additional information received reported that the patient didn't feel any stimulation differences between the right and aberrant impedance so that's why they didn't try to fix them.The stimulation was dysfunctional, but it was not linking to the device.The etiology was updated to possibly related to the device or therapy, and probably related to the implant procedure.It was noted that the device was explanted and replaced.The device diagnosis was the lead being placed too low and too right.

• 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: 18230933
• MDR Text Key: 329279379
• Report Number: 3004209178-2023-24376
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: 05/14/2018
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/28/2023
• Date Device Manufactured: 04/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 93 KG