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

Model Number	97725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)
Date of Event	02/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Product id: 977a275, serial/lot #: (b)(4), ubd: 23-dec-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received via a manufacturer representative from a health care professional regarding a patient who was undergoing a trial for spinal cord stimulation.It was reported that the patient had a trial lead placed on (b)(6) 2020.The health care professional did a partial laminectomy to get this lead into proper position in the cervical spine.The patient had pain related to the laminectomy and drainage.The patient was seen on (b)(6) 2020 for the lead pull, and the lead was fully removed and discarded.It was noted that the patient may have a possible infection.The patient has a fever and was put on antibiotics on (b)(6) 2020.It remains unknown if the issue was resolved.There were no further complications reported or anticipated.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 9794050
• Report Number: 3007566237-2020-00303
• Device Sequence Number: 11334871
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 04/10/2021
• 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: 02/10/2020
• Initial Report FDA Received Date: 03/05/2020
• 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: Required Intervention
• Patient Age: 47 YR