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

Model Number	37701
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949); Positioning Problem (3009)
Health Effect - Clinical Codes	Incontinence (1928); Electric Shock (2554); Insufficient Information (4580)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
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
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient called because she had surgery yesterday to replace the battery however said that when the surgeon opened up the site, they weren't familiar with the product: said that there were two leads so the procedure was aborted.Patient said that the representative (rep) said that he wasn't familiar with the product either.Patient services reviewed device information and explained that the components (ins and extension) implanted are from a different line of therapies whereas the lead is for interstim.Patient said that the procedure was postponed four times, twice as patient was sick (unrelated) and then once by the rep and then healthcare professional (hcp).Patient stated that after the last attempted surgery explained below the patient did not have bladder control for 2 days. .
Event or Problem Description
Additional information was received from the patient (b)(6) 2022.Pt reported that they were told to contact their implanting surgeon and were told that the procedure could not be done in (b)(6).Pt had a video appointment on (b)(6) with a healthcare provider.
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.
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
A healthcare professional (hcp) called and reported previously documented information regarding the aborted surgery, and stated the patient reported that since that procedure they have a bump in the location of the ins pocket.
Event or Problem Description
Patient (pt) called in looking for a physician to replace the battery.Patient indicated that the device was implanted for bladder control.The implant is sticking out and visible through clothing.Agent reviewed pelvic health (ph) products.Patient stated they wanted to keep the same device that they have.Patient transferred to spinal cord stimulator (scs).Pt reported getting electrical shocks.Pt repeated when the hcp tried to do a surgery to change the implant, ended up not completing the surgery.They did not check pt's medical records prior to surgery and were not aware pt had an off label scs ins for bladder.During the surgery, hcp did not know what to do and they looked at the rep and the rep did not know what to do either.The rep did not call tech support and nobody knew what to do.Hcp then ended up putting the same ins back and put it in crooked.Rep never called the pt after the surgery.And now pt felt it every time they go to the bathroom and get in the car.Now pt was getting shocks and thought they turned ins off but maybe they did not.The issue started about 3 weeks ago.Pt was seeing another urologist and hcp said they only saw one lead and said they could only take the implant out but the lead will break off if hcp tries to take it out.Hcp said 'once we take them out, they break and you cannot have another one".Pt then did not want to do anything and would like to get a new stimulator that has 2 leads.Pt mentioned they had been looking for hcp/surgeon for 2.5 years and had no luck.Nobody would see pt due to insurance.Pt asked if there is a pain hcp in their area who could replace the battery.Redirected to follow up with a urologist.Emailed ph hcp listings.Agent consulted with scs and ph principles and reassigned case to email scs and ph reps to see if they know of a hcp who may be able to help this patient.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Patient called back extremely escalated and mentioned they called all the doctors from the previous listing but they could not find one doctor that would remove their two leads.One doctor mentioned that if they removed the leads then the leads would break.Patient could only find doctors that would install implants but not remove their lead.Agent tried to review information but patient would not let agent talk and patient was just extremely escalated.Patient wanted the agent to call the doctors or find a doctor for the patient.

• Brand Name: RESTORE PRIME
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15140709
• Report Number: 3004209178-2022-09728
• Device Sequence Number: 17958865
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 06/26/2025

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: 08/14/2013
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 03/13/2023; 05/07/2025; 06/10/2025
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/27/2022; 03/17/2023; 05/20/2025; 06/26/2025
• Date Device Manufactured: 02/24/2012
• 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 Age: 65 YR
• Patient Sex: Female