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 Post Operative Wound Infection (2446)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: alleged infection.There was no mainstay medical representative at the time of the explant procedure; therefore, no product was returned for evaluation.However, a review of manufacturing and sterilization records revealed no non-conformances or any indication that the device would have contributed to the alleged infection.Explanted stimulation leads (81xx).D20900817 / d20900818.Mmlreference#: (b)(4).

Event Description

It was reported that the patient who was implanted with the reactiv8 system had an explant due to a suspected post-operative wound infection.The patient had a low-grade temperature of 99.0, drainage from the implantable pulse generator ( ipg) site incision, and the left flank showed mild perincisonal erythema and superficial skin loss about the size of nickel caudal to the midline.Reportedly, the patient admitted picking at the incision site for 5-7 days until he noticed it opened.The patient reported doing well after the explant.The culture result was negative for infection.The patient was treated with antibiotics intravenous at the time of the explant.The device was implanted on (b)(6) 2022 without complications.At the two-week post-op wound check and activation appointment, both incisions were clean, dry, and intact.No erythema was present.

• 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: 16373520
• MDR Text Key: 309509383
• Report Number: 3013017877-2023-00006
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527770015
• UDI-Public: (01)05391527770015
• 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: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White