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 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Mml ref#:(b)(4).

Event Description

During the patient's follow-up visit, one electrode on the right side was found to have an out-of-range/high-impedance failure.Upon investigation, the patient reported having difficulty activating the device.The therapy manager reprogrammed the device with the remaining working electrode of the right lead.The patient continues to have bilateral stimulation.However, the surgeon decided to replace the right lead.The patient underwent revision surgery.The right lead was removed and intact.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: 18900823
• MDR Text Key: 337781487
• Report Number: 3013017877-2024-00011
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064(11)211222(17)241201
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Date Device Manufactured: 12/22/2021
• 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