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

Model Number	37702
Medical Device Problem Codes	Failure to Deliver Energy (1211); Unintended Collision (1429); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is month and year valid.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
Information was received, from a patient.Who was implanted with an implantable neurostimulator (ins).The reason for call, was patient reported, they were in a car accident on october 7th.And the issue began, after the car accident or a little bit the next day.That all of a sudden, their stimulator stopped working and they couldn't feel stimulation.The patient was redirected to their healthcare provider to further address the issue.Agent provided nas phone number.Case reopened and reassigned to email medtronic rep.Pt called, back stating, already documented events.And they contacted their hcp office to set up an appointment, but the hcp office would not set it up.Agent reviewed a message would be sent to the reps and encouraged pt to call their hcp office again.Agent closed case.Mdt rep called, to report they were notified friday night that the patient was in an accident in october, at which time they stated, their implant stopped working.Rep did not know the nature of the device not working, as they had not yet met with the patient.Ts reviewed how to attempt connection with the ins and reviewed eri/eos for this device.Rep stated, they plan to see the patient today and will call back with details or to request information on programming, if needed.Ts provided, this case number to the caller.Rep called back and said, they can connect to the implant and it showed low battery.And that therapy can't be turned on.Technical services(ts) reviewed with rep, there is not anything else they can do to turn therapy on.
Event or Problem Description
Additional information was received from the rep.Cause is unknown.Patient has scheduled an appointment with surgeon to discuss replacement of spinal cord stimulator battery.The issue has not been resolved.Patient has been waiting for appointment with surgeon.Rep confirmed patient will share information with surgeon.
Additional Manufacturer Narrative
H1: additional information was received.Updating from malfunction reportable to serious injury reportable.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
Additional information was received from a manufacturer representative (rep).An explant date has not yet been scheduled, the issue is not resolved, and the patient is working with the surgeon to schedule replacement.

• Brand Name: PRIMEADVANCED
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20797102
• Report Number: 3004209178-2024-22748
• Device Sequence Number: 7808718
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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: 09/14/2015
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 03/28/2025; 04/29/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/18/2025; 05/16/2025
• Date Device Manufactured: 03/24/2014
• 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: 60 YR
• Patient Sex: Female