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

Model Number 8145 / 5100

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

Patient Problem Implant Pain (4561)

Event Date 12/19/2023

Event Type  Injury  

Event Description

It was reported that the reactiv8 system was explanted due to non-efficacy and patient compliance due to discomfort during therapy.The patient reported increased hip pain and abdominal contractions during therapy sessions.Mainstay medical attempted to program the device, and even though the midline contraction was established, the patient consistently reported therapy discomfort.Reportedly, the patient was advised to limit her activity acutely for the initial period after the implant procedure, but the patient struggled to restrict her activity.According to the patient, she has been in labor-intensive volunteering, church activities, and long walks, which will be difficult for her to stop.Before the reactiv8 implant, the patient had a groin sensation and a hip pain health issue.A review of the implant images revealed a slight suboptimal placement of the right lead.It is difficult to ascertain the magnitude of contribution the suboptimal placement of the right lead had on the non-efficacy of the therapy, the discomfort experienced by the patient, or whether the system was effected post implant by the patient's activity.The device was removed with no report of patient harm or injury.

Manufacturer Narrative

Mml reference: (b)(4).B2-other: pain/discomfort.Other device explanted: model: 5100, description: implantable pulse generator: s/n: (b)(6), uid: (b)(4), model: 8145, description: implantable stimulation lead: udi: (b)(4).

Manufacturer Narrative

Mml reference: (b)(4).B2-other: pain/discomfort.The device was received and evaluated.No problems were identified during the evaluation.The device history record review revealed no evidence of a nonconformance found during the manufacturing of this device that could contribute to the patient's alleged pain/discomfort.

Event Description

It was reported that the reactiv8 system was explanted due to non-efficacy and patient compliance due to discomfort during therapy.The patient reported increased hip pain and abdominal contractions during therapy sessions.Mainstay medical attempted to program the device, and even though the midline contraction was established, the patient consistently reported therapy discomfort.Reportedly, the patient was advised to limit her activity acutely for the initial period after the implant procedure, but the patient struggled to restrict her activity.According to the patient, she has been in labor-intensive volunteering, church activities, and long walks, which will be difficult for her to stop.Before the reactiv8 implant, the patient had a groin sensation and a hip pain health issue.A review of the implant images revealed a slight suboptimal placement of the right lead.It is difficult to ascertain the magnitude of contribution the suboptimal placement of the right lead had on the non-efficacy of the therapy, the discomfort experienced by the patient, or whether the system was effected post implant by the patient's activity.The device was removed with no report of patient harm or injury.

• 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: 18531595
• MDR Text Key: 333086802
• Report Number: 3013017877-2024-00002
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015(11)220602(17)240617(10)H4836
• 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,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8145 / 5100
• Device Catalogue Number: 8145 / 5100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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 Sex: Female
• Patient Weight: 82 KG
• Patient Race: White