MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED 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 10/28/2022

Event Type  Injury  

Manufacturer Narrative

Mml reference # (b)(4).Investigation conclusion: patient discomfort.Customer phone number: (b)(6).

Event Description

It was reported that the patient underwent revision surgery procedure because the patient experienced pocket pain.The implantable pulse generator (ipg) was repositioned in the same pocket but more lateral to avoid pain triggers.There was no part replaced.The device remains implanted.The revision surgery was successful with no report of patient harm or injury.The manufacturing record of this device was reviewed and no relevant nonconformities were found.

Manufacturer Narrative

On 3/10/2023: updated h6- investigation conclusion: the patient was implanted with the reactiv8 system for more than a year and was doing well before the reported pocket pain discomfort.The manufacturing record of this device was reviewed, and no relevant nonconformities were found.Additional information was received and indicated that the patient could not differentiate where the pain came from if back or pocket pain.The physician's physical examination of the patient stated the implantable pulse generator (ipg) triggered the pain- a surgical procedure repositioning the ipg resolved the issue.The patient's pain level was reduced to 50%, and less pain medication.Mml reference # (b)(4).Investigation conclusion: patient discomfort customer phone number: (b)(6).

Event Description

It was reported that the patient underwent revision surgery procedure because the patient experienced pocket pain.The implantable pulse generator (ipg) was repositioned in the same pocket but more lateral to avoid pain triggers.There was no part replaced.The device remains implanted.The revision surgery was successful with no report of patient harm or injury.The manufacturing record of this device was reviewed and no relevant nonconformities were found.

• Brand Name: REACTIV8
• Type of Device: 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: 15761349
• MDR Text Key: 303337515
• Report Number: 3013017877-2022-00020
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770008
• UDI-Public: (01)05391527770008
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2019
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG