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 02/06/2023

Event Type  malfunction  

Event Description

It was reported that the all four electrodes on the left stimulation lead were out of range.As a result, the patient underwent a revision surgery to have the left lead replaced.The revision surgey was successfull with no report of patient harm or injury.

Manufacturer Narrative

Mml ref: (b)(4).

Event Description

It was reported that the all four electrodes on the left stimulation lead were out of range.As a result, the patient underwent a revision surgery to have the left lead replaced.The revision surgey was successfull with no report of patient harm or injury.

Manufacturer Narrative

Mml ref: (b)(4).The returned left lead assembly was lost during transit.If the part is received, an investigation will be performed, and a supplemental report will be submitted.Additional information was received that the patient was initially reported could not activate the device.The patient was provided an activator but could not start a session with the new activator.The therapy manager saw the patient on (b)(6) 2022 to troubleshoot the issue, finding three electrodes out of range and excluded.At that time, the patient was reprogrammed with the working electrode of the left lead and the implantable pulse generator (ipg) can.The patient was able to start bilateral stimulation.The doctor recommended a revision surgery to replace the left lead.During the revision surgery to replace the left lead, the right lead was tested nominal for impedance and was removed from the right header and placed to the left header to rule out any issue with the ipg possibly being the cause of the oor.Lead and header impedances were nominal.In placing the right lead back in the right header, electrode 5 on the right lead became oor.The right lead was secured and remained in the right header, and the left lead was implanted and placed in the left header.All impedances were nominal except for the #5 electrode.The patient was tested afterward and achieved good contractions without programming using the #5 electrode.

• 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: 16482412
• MDR Text Key: 310693336
• Report Number: 3013017877-2023-00009
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 85 KG