MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIV8; REACTIV8 PERCUTANEOUS STIMULATION LEAD

Model Number 8145

Device Problems Failure to Conduct (1114); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the patient had not received optimal therapy since device activation.Initial investigation and review of the post-initial implant images revealed the surgeon placed the lead too far from the target area.The revision surgery was scheduled to replace both leads.During the revision surgery, difficulties were encountered during the extraction of the right lead due to resistance and kink at the loop location, resulting in the lead fracture of the right lead.All pieces were removed.The event was attributed to poor implant technique.The left lead was removed with no issues.Two new leads were implanted with no reports of patient harm or injury.The surgeon was re-trained on proper lead implant techniques and lead positioning.Following the lead revision, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.

Manufacturer Narrative

Mml reference #: (b)(4).

Manufacturer Narrative

Mml reference #: (b)(4).The device was received and evaluated.No problem was identified that could contribute to the suboptimal lead placed/migration.The leads were replaced due to poor placement by the surgeon.

Event Description

It was reported that the patient had not received optimal therapy since device activation.Initial investigation and review of the post-initial implant images revealed the surgeon placed the lead too far from the target area.The revision surgery was scheduled to replace both leads.During the revision surgery, difficulties were encountered during the extraction of the right lead due to resistance and kink at the loop location, resulting in the lead fracture of the right lead.All pieces were removed.The event was attributed to poor implant technique.The left lead was removed with no issues.Two new leads were implanted with no reports of patient harm or injury.The surgeon was re-trained on proper lead implant techniques and lead positioning.Following the lead revision, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 PERCUTANEOUS STIMULATION LEAD
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, dublin K67F2 ; EI K67F2
• Manufacturer Contact: liza dominguez ; 6601 shingle creek parkway; suite 200; brooklyn center, MN 55430 ; 6192063331
• MDR Report Key: 18798940
• MDR Text Key: 337518682
• Report Number: 3013017877-2024-00007
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064(11)220922(17)251001
• 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,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8145
• Device Catalogue Number: 8145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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 Age: 81 YR
• Patient Sex: Female