MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE PULSE GENERATOR

Model Number 5100

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

Patient Problem Implant Pain (4561)

Event Date 11/06/2023

Event Type  Injury  

Event Description

The patient was implanted with the reactive system on (b)(6) 2023.The patient reported pain around the implantable pulse generator (ipg) pocket.I t was reported (date unknown) that the ipg pocket was injected with lidocaine to help alleviate the pain/discomfort.Reportedly, (date unknown) the patient then developed an infection at the ipg pocket site.A culture was taken and confirmed the type of infection was staphylococcus aureus.The patient was given an oral antibiotic (levaquin), and the patient underwent surgery to relocate the ipg site from the flank to the buttock.There was no report of patient harm or injury.Mainstay medical was unaware of this event and was not present during the ipg relocation surgery.The device manufacturing record was reviewed - no non-conformance was found that would have contributed to the alleged infection.

Manufacturer Narrative

Mml reference # (b)(4).B2 other: site pain/discomfort/ infection.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18322659
• MDR Text Key: 330428985
• Report Number: 3013017877-2023-00054
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5100
• Device Catalogue Number: 5100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2022
• 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): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White