MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	37703
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
2022-jul-28 rtg0332903 (con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient reported that they are needing their ins replaced and was supposed to have replacement surgery, but surgery was postponed because the hcp needs a lead replaced before they can implant the new ins.Patient reported that their ins had died.Additional information was received from the patient on (b)(6) 2022.They reported they first noticed that the ins had died in (b)(6) 2022, and had contacted the manufacturer at that time about it.Nothing has been done yet.They don't know why the "wire" needs to be replaced.They stated their surgery on (b)(6) 2022 was postponed after they were in the surgical room and "out".The doctor decided they needed another orthopedic doctor to help with the surgery, whom the pt ended up seeing on august 30th.Patient weight was provided.
Additional Manufacturer Narrative
Concomitant medical products: product id: 3988nds, lot#: n24396, implanted: 2000-11-30, product type: lead.Other relevant device(s) are: product id: 3988nds, serial/lot #: (b)(4), ubd: , udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Continuation of d10: product id 3988nds lot# n24396 serial# implanted: (b)(6) 2000 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.
Event or Problem Description
Additional information received.Patient reported lead wire wouldn't work with new ins.Patient reported unable to find anyone to remove device.
Additional 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 or Problem Description
Rep reported the patient¿s itrel battery was implanted in (b)(6) 2013.Rep believe it went dead due to natural depletion.Patient reported their doctor said the wire was old and wouldn't work with the medtronic device so it needed to be replaced.It was located from right ankle to just below knee.Patient reported hcp didn't do an incision.Hcp looked at it and realized they couldn't do it.They gave patient meds that put them out.Patient saw pa twice before surgery.Surgery was scheduled for (b)(6) 2022 but patient is still trying to find a doctor that could do the surgery.Ins died in (b)(6) 2022 and now patient's walking is getting worse.
Additional Manufacturer Narrative
Continuation of d10: product id 3988nds lot# n24396 serial# implanted: (b)(6) 2000,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.
Event or Problem Description
Additional information was received from a healthcare provider (hcp) on 2023-01-25.The caller stated they need to contact a rep for a peripheral nerve stimulator that needed to be replaced.It was revealed they have a 37703 and it was confirmed that this was the device that needed replacing.Caller also stated patient may require another ins to be implanted as well.Caller stated that per medical chart, the patient has tried to have this replaced in the past and "nobody will do it".Caller also stated the medical chart does not indicate a reason for replacement other than the ins died in (b)(6) 2022.After confirming that they would contact an scs rep, caller indicated she was already aware of scs reps who she has tried to contact but has not yet heard back from them.Caller planned to reach out to them again.Caller did not provide date of when they were contacted, initially, however when called back, the caller indicated they were contacted yesterday.

• Brand Name: ITREL 4
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 15478847
• Report Number: 3004209178-2022-12349
• Device Sequence Number: 5836088
• Product Code: LGW
• UDI-Device Identifier: 00643169107793
• UDI-Public: 00643169107793
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2014
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/28/2022; 01/25/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/26/2022; 11/18/2022; 01/26/2023
• Date Device Manufactured: 01/30/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG