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 01/11/2023

Event Type  Injury  

Manufacturer Narrative

Mml reference#: (b)(4).Outcomes attributed to adverse event: surgical procedure to reposition the device.Customer phone number: (b)(6).

Event Description

It was reported that the patient experienced pocket pain at the implantable pulse generator (ipg) site.The patient underwent a surgical procedure to reposition the location of the ipg.The event was successful, with no report of patient harm or injury.The device remains implanted and functional.

Manufacturer Narrative

Mml reference # (b)(4).B2 other: surgical procedure to reposition the device.Customer phone number:(b)(6).3/21/2023: updated h6 conclusion code.The patient was implanted with the reactiv8 system on (b)(6) 2022 and was doing well before the reported pocket pain discomfort.The manufacturing record of this device was reviewed, and no relevant nonconformities were found.The x-rays images from the post-initial implant and pre-surgical procedure to reposition the ipg revealed the ipg was located in a typical position.Per the implant and programming manual, a known risk associated with surgery, implantation of a medical device, or use of reactiv8 is acute or persistent pain, and/or discomfort due to the presence of the device.There is no further report of pain after the repositioning of the ipg.

Event Description

It was reported that the patient experienced pocket pain at the implantable pulse generator (ipg) site.The patient underwent a surgical procedure to reposition the location of the ipg.The event was successful, with no report of patient harm or injury.The device remains implanted and functional.

• 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: 16297658
• MDR Text Key: 308784158
• Report Number: 3013017877-2023-00002
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2021
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White