MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS¿; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	977118
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an implanted lead 977a260 5mm compact 1x8 experienced a recent fall, return of pain, and new pain unrelated to baseline.The physician expressed concern for possible lead migration or dislodgement following the fall, with concerns regarding pain coverage.The patient and provider requested reprogramming and lead assessment.X-ray imaging and evaluation by the physician were scheduled to assess lead impedances, programming, and pain coverage.The issue remained ongoing.The manufacturer representative (rep) indicated they would send any further information as they become aware.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(6), ubd: 04-mar-2030, udi#: (b)(4).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.

• Brand Name: INTELLIS¿
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
• 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 ; +1(763)526-5677
• MDR Report Key: 50916294
• Report Number: 3004209178-2026-16409
• Device Sequence Number: 20181897
• Product Code: LGW
• UDI-Device Identifier: 00763000984656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: 977118
• Device Catalogue Number: 977118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 03/05/2026
• 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: "See H11...."
• Patient Age: 56 YR
• Patient Sex: Male