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

Model Number 8145

Device Problem Failure to Conduct (1114)

Patient Problem Failure of Implant (1924)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that the patient was having difficulty activating the device.The therapy manager troubleshot the issue with the patient and confirmed that the right lead had a progression of out-of-range/high impedance failure.The device was reprogrammed to unilateral stimulation until a revision surgery could be scheduled.The device continues to deliver stimulation.The patient underwent revision surgery to replace the right lead, and during the surgery, the surgeon decided to replace the left lead as a precaution to avoid future surgery.Both leads were removed intact, and two new leads were implanted.There was no report of patient harm or injury.

Manufacturer Narrative

Mml ref #: (b)(4).Other device explanted: model: 8145.Description: stimulation lead.Serial number: (b)(6).Udi: (b)(4).No patient information available due to the privacy law.

Event Description

It was reported that the patient was having difficulty activating the device.The therapy manager troubleshot the issue with the patient and confirmed that the right lead had a progression of out-of-range/high impedance failure.The device was reprogrammed to unilateral stimulation until a revision surgery could be scheduled.The device continues to deliver stimulation.The patient underwent revision surgery to replace the right lead, and during the surgery, the surgeon decided to replace the left lead as a precaution to avoid future surgery.Both leads were removed intact, and two new leads were implanted.There was no report of patient harm or injury.

Manufacturer Narrative

Mml ref #: (b)(4).Other device explanted: model: 8145; description: stimulation lead, serial number: (b)(6), udi: (b)(4).The lead assemblies were returned and evaluated.The reported issue was verified.The analysis confirmed lead conductor fractures were the cause of the high impedance conditions observed with the right percutaneous stimulation lead.Updated section h6 and device udi number.

• Brand Name: REACTIV8
• Type of Device: REACTIV8 PERCUTANEOUS STIMULATION LEAD
• 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: 18682686
• MDR Text Key: 336195903
• Report Number: 3013017877-2024-00004
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064(11)211222(17)241201
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• 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 Age: 26 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White