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 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

Mml reference # (b)(4).Other device explanted: model: 8145, description: percutaneous stimulation lead, serial number: (b)(6), and udi #: (b)(4).

Event Description

It was reported that the patient underwent revision surgery due to the progression of out-of-range/high impedance failure of the right lead.There was no report of patient harm or injury.Both leads were removed and intact.Two new leads were implanted.Although the left lead was functional, the surgeon replaced it as a precaution to avoid another revision.Following the lead revision, the reactiv8 system was activated by programming the reactiv8 ipg to allow the patient to initiate bilateral stimulation.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.

• 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: 18794963
• MDR Text Key: 337628120
• Report Number: 3013017877-2024-00008
• Device Sequence Number: 1
• Product Code: QLK
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 120 KG