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

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot# /serial# (b)(4) 7, implanted: (b)(6) 2021 , product type: lead ; product id: 977a260 , lot# / serial# (b)(4) , implanted: (b)(6) 2021 ,product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4) , ubd: 19-apr-2025, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4) , ubd: 12-feb-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via a health care provider (hcp) and manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient had a fever and some discharge at lead site.Physician suspected possible infection.Opened incision sites at leads and ins to take a culture for possible infection.The issue was reported to be resolved at the time of the report.

• Brand Name: INTELLIS
• Type of Device: 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12094230
• MDR Text Key: 266420122
• Report Number: 3004209178-2021-10192
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR