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

Model Number	37702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name specify; product id 39565-65 (b)(6); product type: 0200-lead; implant date (b)(6) 2013; explant date (b)(6) 2020.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 via healthcare provider who was implanted with an implantable neurostimulator (ins).It was reported the patient had a hybrid system with another manufacturers devices, and the patient reported ineffective coverage.A possible revision was planned, and during intra-operative testing, they were able to adequately get low back and right leg pain coverage, which was patient's primary complaints.Fluoroscopy showed no evidence of lead migration.The hcp elected to not proceed further with revision that appeared to be functioning after adequate testing.Information indicates the system was removed instead.

• Brand Name: PRIMEADVANCED
• 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: 21181163
• Report Number: 3004209178-2025-01017
• Device Sequence Number: 4262285
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2014
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/17/2025
• Date Device Manufactured: 01/21/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female