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 01/20/2023

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: severe pain.Mml ref # (b)(4).

Event Description

It was reported that the patient was implanted with the reactiv8 system on (b)(6) 2022.The patient called on (b)(6) 2022 to report severe surgical/incisional pain at the implantable pulse generator (ipg) pocket site.The patient was prescribed an antibiotic, morphine, and short-acting opioids daily post-operative medication.The patient requested an explantation and claimed she was unaware of the post-operative pain.The surgeon advised the patient that the pain would improve in the next 48-72 hours.The patient was seen in the clinic on (b)(6) 2022 and was assured that she will continue to improve.However, the patient continued to report ipg pocket pain and requested an explant.The device was explanted on (b)(6) 2023 with no reports of patient harm or injury.The reactiv8 system was evaluated, and the manufacturing record was reviewed.There were no non-conformances found.

• 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: 16387345
• MDR Text Key: 309677465
• Report Number: 3013017877-2023-00007
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 0539152777001
• UDI-Public: (01)0539152777001
• 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: Other
• Type of Report: Initial
• Report Date: 02/16/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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