MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7425

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  Injury  

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was the pt reported they just had a battery taken out and the surgeon was going to put in an abbott but from what pss understood there was an issues with the patient's lead(s).Pt said the hcp was not able to take the one in them out because they had it for so long and it could cause more paralysis than what they already have.Pt indicated they were directed to manufacturer to see if their was a battery that would match what they have inside them or if manufacturer could put an abbot battery in.Pss understood pt was referring to an upgraded neurostimulator (ins) battery that would be compatible with the implanted leads.The last time their spinal cord stimulator (scs) was worked on was 2007.Pt noted they were in a nursing home.Pt stated they had met with their hcp today (dr.Wall for an evaluation) at back <(>&<)> spine in (b)(6).Pt stated the hcp already had the battery ready for the procedure but just took the old battery out because it was dead.Pt asked was there a way to fix the already implanted electrodes or could they go with abbott.Pss was also initially unable to locate pt file under name provided.Pt claimed there were no other names used during time with manufacturer.After searching the system pss was able to locate pt by a different last name pss called pt back to confirm this was in fact their previous last name.Pss was having difficulty understanding everything pt was saying.Also, information seemed conflicting.Agent did not ask about the circumstances that led to the reported issue.Pss offered to email territory reps to coordinate communication with the pt since hcp redirected them to pats.Pss provided the pt with the nas number for their hcp office if needed.On 2023-jul-16 rtg0465125  (follow up/additional info): upon further review: pss will follow up with pt on next bossiness day to clarify information regarding leads and revision/replacement.On 2023-jul-18 rtg0465125  (follow up/additional info): pss reached out to pt to clarify event date.Pt noted the defective leads was discovered when they went for a neurostimulator (ins) battery upgrade at the end of (b)(6) this year.They believe the date was (b)(6) 2023.Pt confirmed they had yet been contacted by a mdt rep.Pss provided hcp's contact number and nas's for office to locate assigned territory rep.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name resume ii; product id 3587a; product type: 0200-lead; implant date (b)(6)1997.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 3587a serial# (b)(6) implanted: (b)(6) 1997: 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 reason for call was caller stated they had a pt in a nursing home whose scs was no longer working and pt had been sent to clinic in area to get the scs removed and put a new scs device in, but hcp was trying to leave leads in and caller wanted to know extension compatibility information.

• Brand Name: ITREL 3
• Type of Device: 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: 17384845
• MDR Text Key: 319827525
• Report Number: 3004209178-2023-13162
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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: 10/28/2008
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/20/2023
• Date Device Manufactured: 05/10/2007
• 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
• Treatment: "SEE H10...."; SEE H10...
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female