MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ PERIPHERAL NERVE STIMULATOR

Model Number FR4A-RCV-A0Q

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) stimq receiver stimulator (stq4-rcv-a0) was implanted at the ulnar nerve.The territory manager confirmed the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the territory manager maintained contact with the patient following implant.On (b)(6) 2019, the patient reported a potential infection and irritation to the territory manager.The patient visited the implanting clinician's office on (b)(6) 2019, for follow up.The implanting clinician evaluated the implant and noticed the implant site was irritated.The patient had a rash along the implant site.The implanting clinician decided to prescribe antibiotics for three (3) days.The patient was sent home the same day.On (b)(6) 2019, the patient followed up once again.The implanting clinician noticed the irritation had diminished but noticed a protuberance at the implant site.The implanting clinician performed blood tests on the patient and the results demonstrated the patient did not have any infection markers.However, the implanting clinician did not want to rule out an infection.On (b)(6) 2019, the patient followed up once again with the implanting clinician for additional testing.The implanting clinician believed the patient had a hematoma approximately the size of an orange beneath the flexible board of the stimulator.The implanting clinician proceeded to perform ultrasound imaging tests.Ultrasounds demonstrated that the patient potentially has a hematoma at the implanted location.Further review of the patient's medical history demonstrated the patient has multiple comorbidities that could have attributed to the event.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for either lot, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause is attributed to patient comorbidities.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is not attributed to the device.This is the first reported issue of hematoma.Stimwave will continue to track and trend this type of event.Stimwave was in constant contact with the territory manager from november 1, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to patient conditions.Stimwave has informed all parties that the product was not the source issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable as the event to the united states food and drugs administration (fda) as the event resulted in a serious injury.The event was reported to the united states food and drugs administration (fda) on november 26, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a potential infection, tissue damage and skin irritation reported to stimwave on november 1, 2019, by the territory manager.

• Brand Name: STIMQ PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9379160
• MDR Text Key: 168282369
• Report Number: 3010676138-2019-00059
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020075
• UDI-Public: (01)00818225020075(17)200801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2020
• Device Model Number: FR4A-RCV-A0Q
• Device Lot Number: SWO180815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2018
• 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 Outcome(s): Required Intervention