MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 IMPLANTABLE PULSE GENERATGOR

Model Number 5100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that the patient was benefiting from the therapy.However, the patient continuously experienced pocket pain discomfort despite relocating the ipg on (b)(6) 2023.The patient requested the reactiv8 system be explanted.The device was explanted.There was no report of patient harm or injury.Unrelated to the ipg removal, three electrodes were more difficult to remove during the removal of the left lead and were left inside the patient at the surgeon's discretion.The ipg and right lead were intact when removed.The reposition procedure in (b)(6) 2023 was reported at the same time as the explant procedure.

Manufacturer Narrative

Mml ref: (b)(4).B2-other: site pain/discomfort.Other device explanted: model: 8145.Description: percutaneous stimulation lead.Serial numbers: (b)(6).Udi: (b)(4).

Event Description

It was reported that the patient was benefiting from the therapy.However, the patient continuously experienced pocket pain discomfort despite relocating the ipg on a(b)(6) 2023.The patient requested the reactiv8 system be explanted.The device was explanted.There was no report of patient harm or injury.Unrelated to the ipg removal, three electrodes were more difficult to remove during the removal of the left lead and were left inside the patient at the surgeon's discretion.The ipg and right lead were intact when removed.The reposition/relocation of the ipg procedure in (b)(6) 2023 was reported at the same time as the explant procedure.

Manufacturer Narrative

Mml ref: (b)(4).B2-other: site pain/discomfort.Other device explanted: model: 8145.Description: percutaneous stimulation lead.Serial numbers: (b)(6).Udi:(b)(4).The reactiv8 system was returned and evaluated.There was no fracture of wire observed in the returned leads.The implantable pulse generator (ipg) passed the functional test.There was no allegation against the function of the lead or the ipg.The reactiv8 system was removed at the patient's request.Per the implant and programming manual, a known risk associated with surgery, implantation of a medical device, or use of reactiv8 is acute or persistent pain and/or discomfort due to the presence of the device.Manufacturing report number 3013017877-2023-00053 documented the event on april 6, 2023.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATGOR
• 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: 18162671
• MDR Text Key: 328430836
• Report Number: 3013017877-2023-00051
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015
• 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,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5100
• Device Catalogue Number: 5100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Race: White