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 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Mml ref # : (b)(4).Patient information has been requested.

Event Description

It was reported that the patient was unable to run therapy.The therapy manager troubleshot the issue and verified that the right lead had an out-of-range/high-impedance failure.The device was reprogrammed with the remaining working electrodes, and the patient continued to run bilateral stimulation.However, the patient continued having issues running therapy.It was confirmed that the right lead had an out-of-range/high-impedance failure progression.The therapy manager reprogrammed the device to unilateral stimulation on the left side and increased ¿s for a more centralized and diffuse contraction.The physician and the patient were advised about undergoing revision surgery to replace the right lead.However, the physician wanted to go conservative since the patient's back pain was resolved.The patient continues using the device with unilateral stimulation with no issues.Seven months later, the patient underwent scheduled revision surgery to replace the right lead.The right lead was removed and intact, and a new lead was implanted.There was no report of patient harm or injury.

• 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: 19009226
• MDR Text Key: 338981525
• Report Number: 3013017877-2024-00015
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• 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
• Date Manufacturer Received: 12/22/2023
• Date Device Manufactured: 07/20/2021
• 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