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 07/12/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced pocket pain.The patient was implanted with the reactiv8 system over a year ago and has benefitted from therapy since activation.The doctor had attempted some localized injections to reduce the pocket pain.The patient had some relief but continued to experience pocket pain and requested the reactiv8 system be explanted.There was no report of patient harm or injury.The device was explanted successfully.

Manufacturer Narrative

Mml reference # (b)(4).B2-other: pocket paint/discomfort.Other devices explanted: model #: 8145.Description: implantable stimulation leads.Serial numbers: (b)(6).Udi: (b)(4).

Manufacturer Narrative

Mml reference # (b)(4).B2-other: pocket paint/discomfort.Other devices explanted: model #: 8145 description: implantable stimulation leads serial numbers: (b)(6).Udi: (01)05391527772064 the devices were returned for evaluation.There was no allegation against the function of the ipg and stimulation leads.No observation would affect the function of the ipg and the stimulation leads.

Event Description

It was reported that the patient experienced pocket pain.The patient was implanted with the reactiv8 system over a year ago and has benefitted from therapy since activation.The doctor had attempted some localized injections to reduce the pocket pain.The patient had some relief but continued to experience pocket pain and requested the reactiv8 system be explanted.There was no clear evidence that the ipg had moved from location.There was no report of patient harm or injury.The device was explanted successfully.

• 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: 17439929
• MDR Text Key: 320204193
• Report Number: 3013017877-2023-00028
• Device Sequence Number: 1
• Product Code: QLK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/02/2023
• 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: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 65 KG