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 01/02/2024

Event Type  malfunction  

Event Description

It was reported that the patient had difficulty activating the device.The therapy manager troubleshot the issue with the patient and confirmed that three electrodes of the right lead were out of range/high impedance.The device was reprogrammed to unilateral stimulation, and the patient continued with therapy while revision surgery could be scheduled.There was no report of patient harm or injury.The patient was scheduled to undergo revision surgery of the right lead on (b)(6) 2024.Upon pre-operative interrogation, the left lead showed out-of-range/high impedance on one electrode, and the three remaining electrodes were functional.Both leads were removed and intact.The left lead was replaced to avoid future surgery.Two new leads were implanted successfully.

Manufacturer Narrative

Mml ref #: (b)(4).Other device explanted: model: 8145 description: percutaneous stimulation lead serial number: (b)(6).Udi number: (b)(4).

Manufacturer Narrative

Mml ref #: (b)(4).The lead assemblies were returned and evaluated.The reported issue was verified.The analysis confirmed that lead conductor fractures caused the high impedance conditions observed with the right and left percutaneous stimulation leads.Although requested, the patient's information is not available.

Event Description

It was reported that the patient had difficulty activating the device.The therapy manager troubleshot the issue with the patient and confirmed that three electrodes of the right lead were out of range/high impedance.The device was reprogrammed to unilateral stimulation, and the patient continued with therapy while revision surgery could be scheduled.There was no report of patient harm or injury.The patient was scheduled to undergo revision surgery of the right lead on (b)(6) 2024.Upon pre-operative interrogation, the left lead showed out-of-range/high impedance on one electrode, and the three remaining electrodes were functional.Both leads were removed and intact.The left lead was replaced to avoid future surgery.Two new leads were implanted successfully.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 PERCUTANEOUS STIMULATION LEAD
• 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: 18584696
• MDR Text Key: 334738339
• Report Number: 3013017877-2024-00003
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064(11)210605(17)240601
• 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,Followup
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2021
• 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