MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ITREL 4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	37703
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 3586 lot# serial# (b)(6) implanted: (b)(6) 1997 explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3586, serial/lot #: (b)(6), ubd: , udi#: (b)(4).Mdtmdt 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 or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was caller stated that shortly prior to the implant that was put in 2018, the doctor discovered there was an issue with "one of the leads.Its dead.It wasn't reading.But the other 3 or 4 were".Caller stated they gave the patient the option to change the lead or leave it and caller stated the other ones were working so they didn't want to have the major surgery and decided to just replace the implant and leave the lead in.Patient provided clarification that when third device put in 2018, 2 leads were not working.Hcp (said) that would be okay versus long on operation to replace all leads.The cause was unknown.In 2018, it needed to be replaced.Hcp just replaced the computer and reattached the old leads.In 2018 it just stopped working.Patient was not aware of any additional troubleshooting/diagnostics.Pt is waiting for appointment, september 20.
Event or Problem Description
Additional information received.It was reported replacement was schedule for (b)(6) 2023.
Additional Manufacturer Narrative
Continuation of d10: product id 3586 lot# serial# (b)(6), implanted: (b)(6) 1997, explanted: 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.

• Brand Name: ITREL 4
• Common Device Name: 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: 17908780
• Report Number: 3004209178-2023-17378
• Device Sequence Number: 15364929
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 37703
• Device Catalogue Number: 37703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/09/2023
• Date Device Manufactured: 07/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG