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 01/10/2023

Event Type  Injury  

Manufacturer Narrative

Mml reference # (b)(4).

Event Description

It was reported that the patient who was implanted with the reactiv8 system experienced pain at the implantable pulse generator (ipg) site.The patient is a security service guy who wears a special belt and reported that the belt is pressing force directly on the edge of the implantable pulse generator (ipg).The surgeon decided to perform a surgical procedure to reposition the ipg.There was no report of patient harm or injury due to the event.

Event Description

It was reported that the patient who was implanted with the reactiv8 system experienced pain at the implantable pulse generator (ipg) site.The patient is a security service person who wears a special belt and reported that the belt is pressing force directly on the edge of the implantable pulse generator (ipg).The surgeon decided to perform a surgical procedure to reposition the ipg.There was no report of patient harm or injury due to the event.

Manufacturer Narrative

Mml reference #: (b)(4).The device remains implanted and functional.The manufacturing record of this device was reviewed, and no relevant non-conformances were found that would have contributed to the wear discomfort reported by the patient.The post-initial implant images were requested and not provided to mainstay medical.Therefore, we cannot confirm the root cause of the patient's discomfort.The patient have the ipg repositioned and has been activated.No further reports of wear discomfort have been received.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.

• 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: 16294521
• MDR Text Key: 308755639
• Report Number: 3013017877-2023-00004
• 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: 05/19/2023

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: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2021
• 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): Hospitalization; Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 75 KG