MAUDE Adverse Event Report: MEDTRONIC INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	97725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, lot#: va2blhe007, product type: screening device.Product id: 9 77d260, lot# :va2blhe008, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 12-jan-2025, udi#: (b)(4).Product id: 977d260, serial/lot #: (b)(4), ubd: 12-jan-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturer representative reported that they were to start a trial with this pt on (b)(6) 2021, but the trial was aborted because the pt had pain in the legs that they couldn't tolerate when the doctor was advancing the trial lead.  no device issues were reported.The manufacturer representative has no further information regarding the event as she was told to leave as they were waiting for the ambulance to arrive to the office.Additional information was received from the healthcare provider (hcp).It was reported that the cause of the pain during placement was unclear etiology.The trial was aborted.The patient was admitted to the hospital and workup was negative.The issue was resolved with pain control with meds.Psych consult.The devices were discarded.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC; minneapolis
• MDR Report Key: 12061503
• Report Number: 3007566237-2021-00063
• Device Sequence Number: 3348448
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 05/05/2022
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR
• Patient Weight: 98