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

Model Number 5100

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

Patient Problem Implant Pain (4561)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

Mml ref # (b)(4).B2 other: ipg pocket site pain/discomfort.Other devices: model number: 8145.Description: percutaneous stimulation leads.S/n: (b)(6).Udi #: (b)(4).

Event Description

It was reported that the patient experienced discomfort in the implantable pulse generator (ipg) site pocket area.The patient underwent revision surgery to relocate the ipg from the buttocks to the abdomen at the patient's request.It was also reported that both 45-centimeter (cm) stimulation leads were removed and replaced with 65-cm leads, as the 45-cm leads were too short for the new location of the ipg.There was no allegation against the stimulation leads or the function of the reactiv8 system.The surgery was successful, with no report of patient harm or injury.A review of the device history record revealed no nonconformances during the device's manufacturing.

Event Description

It was reported that the patient experienced discomfort in the implantable pulse generator (ipg) site pocket area.The patient underwent revision surgery to relocate the ipg from the buttocks to the abdomen at the patient's request.It was also reported that both 45-centimeter (cm) stimulation leads were removed and replaced with 65-cm leads, as the 45-cm leads were too short for the new location of the ipg.There was no allegation against the stimulation leads or the function of the reactiv8 system.The surgery was successful, with no report of patient harm or injury.A review of the device history record revealed no nonconformances during the device's manufacturing.

Manufacturer Narrative

Mml ref # (b)(4).B2 other: ipg pocket site pain/discomfort.Other devices: model number: 8145, description: percutaneous stimulation leads, s/n: (b)(6), udi #: (b)(4).Corrected h6- type of investigation & conclusions.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 IMPLANTABLE PULSE GENERATOR (IPG)
• 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: 17456758
• MDR Text Key: 320371975
• Report Number: 3013017877-2023-00032
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2021
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 114 KG