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

Model Number 8145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

The implanted pulse generator (ipg) and leads were returned for evaluation.Ipg was found to be operating within specification.Leads were unable to be evaluated due to damage during explantation.

Event Description

It was reported that the patient underwent an explant for the reactiv8 system.Reportedly patient was dissatisfied with device performance and with clinical care received.Patient chose a surgeon outside of the clinical study to perform the explant.During the explant procedure when the surgeon pulled on the lead, the end cap of the left lead as well as the end cap and most distal electrode of the right lead remained in the patient.Surgeon did not wish to explore further to remove lead fragments.Reportedly, surgeon experienced difficulty utilizing removal tool potentially because of an artery clip obstruction.There has been no report of post surgical complications.No additional patient or event information is available.Note that reactiv8 leads stimulate the peripheral nerves that innervate the multifidus muscle; these are extraspinal and as such the leads are placed outside the spinal canal.

• Brand Name: REACTIV8
• Type of Device: REACTIVE PERCUTANEOUS STIMULATION LEAD
• Manufacturer (Section D): MAINSTAY MEDICAL LIMITED; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• Manufacturer Contact: sanjay sharma ; clonmel house, forster way; swords, county dublin K67F2 ; EI K67F2
• MDR Report Key: 12416933
• MDR Text Key: 269647246
• Report Number: 3013017877-2021-00481
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772019
• UDI-Public: (01)05391527772019(11)171109(17)201101
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2020
• Device Model Number: 8145
• Device Catalogue Number: 8145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other