MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 SYSTEM

Model Number 5100

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

Patient Problem Urticaria (2278)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

B2- other: skin rash.Other devices: model number: 8145.Description: stimulation implantable leads.Serial number: (b)(6).Manufacturing date: 03/19/2022.Mml ref # (b)(4).

Event Description

It was reported that the patient gets skin rash all over his body when the stimulation is activated.The patient requested an explant of the device.The device was explanted successfully with no report of patient harm or injury.The patient reported that the skin rash occurred immediately upon activating the reactiv8 system.There was no medical intervention performed for the rash.According to the patient, the skin rash is exclusively in the back, lasts several days, and occurs every stimulation.The patient confirmed stimulation was not painful.The patient was activated 14 days after the implantation of the device ((b)(6) 2023).The mainstay medical therapy manager and the physician did not notice a rash, and the patient did not complaint of a rash or other issues at the time of activation.A review of the device log, the patient only performed one session per day on average, predominantly delivered in the evening.The device operated as expected.It was not confirmed that the patient experienced a skin rash during stimulation because the patient stopped using the device on (b)(6) 2023.All impedances were stable throughout.After explant, the device was received for evaluation.The implantable pulse generator and the stimulation leads performed normally during testing.A review of the device manufacturing and sterilization revealed no non-conformances that would have contributed to the skin rash reported by the patient.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 SYSTEM
• 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: 17287228
• MDR Text Key: 318778990
• Report Number: 3013017877-2023-00025
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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