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 11/25/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort with the implantable pulse generator (ipg) pocket.The physician decided to perform a pocket revision.The physician repositioned the ipg to a more lateral position to avoid the pocket pain.The procedure was successful, with no report of patient harm or injury.

Manufacturer Narrative

Mml reference#: (b)(4).

Manufacturer Narrative

Mml reference #(b)(4).On 3/20/2023: h1, h6 conclusion code updated and b2 - other (pain/ discomfort).The patient was implanted with the reactiv8 system for over a year and was doing well before the reported pocket pain discomfort.The manufacturing record of this device was reviewed and revealed no evidence of non-conformance found during the manufacturing of the device that could contribute to the pain experienced by the patient.

Event Description

It was reported that the patient experienced discomfort with the implantable pulse generator (ipg) pocket.The physician decided to perform a pocket revision.The physician repositioned the ipg to a more lateral position to avoid the pocket pain.The procedure was successful, with no report of patient harm or injury.

• 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: 15953995
• MDR Text Key: 308038092
• Report Number: 3013017877-2022-00026
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2020
• 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): Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 75 KG