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

Model Number 97715

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

Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Complaint, Ill-Defined (2331)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 04-dec-2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 02-dec-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had an infection.It was reported that a culture was done and it was confirmed to be a staph infection.The rep stated that the patient had a lot of allergies to antibiotics and history of infections needing hospitalization and surgery.The patient was placed on bactrum, given wound care instructions and would be scheduled for an explant.The rep did not provide an exact date that the symptoms started but read from the patient¿s records that they had an office visit with their doctor on (b)(6) 2020.It was noted that the patient had a bump on their back at the implant site (left flank) and pus at the site, but the patient was happy with the pain relief.The patient weighed (b)(6) and was a height of 65 inches.Additional information received from a manufacturer representative (rep).It was reported that the infection site was mid back where the leads were entered and not in the left flank.Device removal was cancelled due to the patient feeling better.The patient was going to re-evaluate removal versus keeping the device.No further complications were reported.

• Brand Name: INTELLIS
• Type of Device: 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10109049
• MDR Text Key: 196740117
• Report Number: 3004209178-2020-09540
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Date Device Manufactured: 02/18/2020
• 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: 56 YR