MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 PERCUTANEOUS STIMULATION LEAD

Model Number 8145

Device Problem Failure to Conduct (1114)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the patient was unable to initiate therapy.There was no report of patient harm or injury.The clinical specialist troubleshot the issue and confirmed that the left lead had a progression of the out-of-range/ high impedance failure.The device was reprogrammed to deliver unilateral stimulation while waiting for revision surgery to be scheduled.On the day of surgery, initial imaging of the left lead showed a complete conductor fracture proximal to electrode 4.Reportedly, during the surgery, significant fibrosis was noted, and considerable dissection was needed to free the leads.During extraction of the left lead, the left lead broke, and all four electrodes of the left lead remained inside the patient.According to the surgeon, the electrodes were too deep to recover.Therefore, all four electrodes of the left lead were left inside the patient.Unrelated to the out-of-range issue, it was reported that the surgeon decided to replace the right lead due to a noticeable kink and was concerned about its long-term viability.One electrode from the right lead was also left inside the patient.The patient reportedly has a relatively high body mass index ( bmi), and all attempted extractions, and placement of the leads was difficult and challenging due to fibrosis.Two new leads were successfully implanted.

Manufacturer Narrative

Mml reference # (b)(4).Although requested, complete patient demographic is unavailable due to the general data protection regulation in the uk.Other lead explanted: model: 8145.Description: percutaneous stimulation lead.Serial number: (b)(6).Udi: (b)(4).

• Brand Name: REACTIV8
• Type of Device: REACTIV8 PERCUTANEOUS STIMULATION LEAD
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18938350
• MDR Text Key: 338251864
• Report Number: 3013017877-2024-00012
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064(11)210520(17)240601
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8145
• Device Catalogue Number: 8145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/19/2024
• Date Device Manufactured: 05/20/2021
• 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 Sex: Female