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 01/17/2023

Event Type  malfunction  

Event Description

It was reported that the patient was implanted with the reactiv8 system on (b)(6) 2022.During the implant, the placement of the left lead was problematic for passing tranverse process (tp).A new lead was used.The patient reported a pulling sensation in the back immediately post-operative period while in recovery and could not gain effective muscle stimulation on the day of activation.Review of the images taken after the implant procedure showed the left stimulation lead was placed sub-optimally.Revision surgery was performed to replace the left and right stimulation leads.There was no report of patient harm or injury.The leads were returned and evaluated.The devices passed functional testing.

Manufacturer Narrative

Mml reference # (b)(4).

Event Description

It was reported that the patient was implanted with the reactiv8 system on (b)(6) 2022.During the implant, the placement of the left lead was problematic for passing tranverse process (tp).A new lead was used.The patient reported a pulling sensation in the back immediately post-operative period while in recovery and could not gain effective muscle stimulation on the day of activation.Review of the images taken after the implant procedure showed the left stimulation lead was placed sub-optimally.Revision surgery was performed to replace the left and right stimulation leads.There was no report of patient harm or injury.The leads were returned and evaluated.The devices passed functional testing.

Manufacturer Narrative

Mml reference # (b)(4).Corrected section e1- contact person.Additional information: the right stimulation lead was replaced as a precaustionary only.Other device: : right percutaneous stimulation lead.Model: 8145.S/n: (b)(6).

• 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: 16340378
• MDR Text Key: 309368215
• Report Number: 3013017877-2023-00003
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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