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

Model Number 5100

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

Patient Problem Implant Pain (4561)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that the patient was implanted with reactiv8 system.Approximately three weeks after the patient was activated, she said she experienced a pocket site discomfort at the implantable pulse generator (ipg) site.The discomfort would last several hours, and then the pain would disappear.The patient also reported that the ipg was shifting at the incision site.The clinical specialist recommended seeing her doctor.The doctor then scheduled the patient to undergo surgery to reposition the ipg.The ipg was repositioned with no report of patient harm or injury.Following the ipg repositioning, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.The manufacturing record of the ipg was reviewed.No non-conformances were found that would have contributed to the pain/discomfort experienced by the patient.The device remains implanted.

Manufacturer Narrative

Mml reference # (b)(4).B2-other: pain/discomfort.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATOR
• 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: 18439964
• MDR Text Key: 331841915
• Report Number: 3013017877-2023-00059
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 01053915277700151122072717240816
• 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
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5100
• Device Catalogue Number: 5100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2022
• 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