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

Model Number 8145

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

Mml reference # (b)(4).

Event Description

It was reported that the patient only felt stimulation on the right side.The therapy manager troubleshot the issue with the patient, and reported being unable to reach perception or muscle activation.The reported issue was verified.X-ray images revealed that the left lead had migrated within the midline incision.The patient was reprogrammed to unilateral stimulation until revision surgery could be scheduled.The patient underwent revision surgery to remove and replace the left lead.The procedure was successful, with no report of patient harm or injury.

Manufacturer Narrative

Mml reference #(b)(4).A review of the x-ray images revealed that the strain relief loops were undersized, the facial entry point of the lead is lateral to the midline, and the ipg was in a very low buttock location (far away caudal from the lead anchoring) which indicates that the surgical techniques were not ideal.The physician will be retrained on standard implant techniques including general surgical considerations.The device was returned and evaluated.The lead assembly passed the functional test and operated within the manufacturing specification.All circuits are intact.

Event Description

It was reported that the patient only felt stimulation on the right side.The therapy manager troubleshot the issue with the patient, and reported being unable to reach perception or muscle activation.The reported issue was verified.X-ray images revealed that the left lead had migrated within the midline incision.The patient was reprogrammed to unilateral stimulation until revision surgery could be scheduled.The patient underwent revision surgery to remove and replace the left lead.The procedure was successful, with no report of patient harm or injury.

• 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: 17438510
• MDR Text Key: 320219498
• Report Number: 3013017877-2023-00031
• Device Sequence Number: 1
• Product Code: QLK
• UDI-Device Identifier: 05391527772064
• UDI-Public: (01)05391527772064
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• 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: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 105 KG