MAUDE Adverse Event Report: MAINSTAY MEDICAL LIMITED REACTIVI8; REACTIV8 PERCUTANEOUS STIMULATION LEAD

Model Number 8145

Device Problem Failure to Conduct (1114)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient was unable to activate stimulation.The patient stated that her back pain had been adversely impacted.The field clinical engineer (fce) verified that the right lead had progressive loss of electrodes due to out-of-range.The fce reprogrammed the device to use unilateral therapy only to cover the period until revision surgery can be scheduled.There was no report of patient harm or injury due to the event.The patient underwent revision surgery on (b)(6) 2023, to remove and replace the right percutaneous stimulation lead.The lead assembly was returned and evaluated.The reported issue was verified.Analysis confirmed lead conductor fractures were the cause of the out-of-range impedance conditions observed with the right percutaneous stimulation lead.

Manufacturer Narrative

Mml reference # (b)(4).

Manufacturer Narrative

Mml reference #(b)(4).Corrected b4: date of submission of this report from 1/4/2023 to 02/03/2023.

Event Description

It was reported that the patient was unable to activate stimulation.The patient stated that her back pain had been adversely impacted.The field clinical engineer (fce) verified that the right lead had progressive loss of electrodes due to out-of-range.The fce reprogrammed the device to use unilateral therapy only to cover the period until revision surgery can be scheduled.There was no report of patient harm or injury due to the event.The patient underwent revision surgery on (b)(6) 2023, to remove and replace the right percutaneous stimulation lead.The lead assembly was returned and evaluated.The reported issue was verified.Analysis confirmed lead conductor fractures were the cause of the out-of-range impedance conditions observed with the right percutaneous stimulation lead.

• Brand Name: REACTIVI8
• 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: 16293875
• MDR Text Key: 308854321
• Report Number: 3013017877-2023-00001
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P190021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

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: 01/16/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• 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