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 08/19/2023

Event Type  Injury  

Manufacturer Narrative

Mml ref #: c-00981.B2 other: pocket pain/discomfort.

Event Description

It was reported that the patient had experienced pocket site discomfort.The patient had lost weight after the reactiv8 implant and use.An x-ray was performed, and the strain relief loop was gone.The surgeon scheduled a revision surgery to prevent possible lead migration.Before the surgical procedure, the mainstay medical representative found that one electrode of the right lead was out-of-range/high impedance.The surgeon decided to replace the right lead on a precautionary basis.During the procedure, the surgeon had difficulty extracting the right lead.Per the surgeon, this was due to a reasonable amount of scar tissue present around distal lead/tines.Ultimately, the right lead fractured, leaving the distal tip of electrodes 5 and 6 in the patient despite multiple attempts to retrieve it.A new lead was implanted, and the implantable pulse generator (ipg) location was relocated.The ipg remains implanted and functional.The procedure was successful with no report of patient harm or injury.Related manufacturer report number 3013017877-2023-00042.

• 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: 17761829
• MDR Text Key: 323577522
• Report Number: 3013017877-2023-00040
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: 0105391527770015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2023
• 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?: Yes
• Date Manufacturer Received: 08/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2021
• 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: 53 YR