MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM-8A NEUROSTIMULATOR; SPINAL CORD STIMULATOR

Model Number FR8A-RCV-A0

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

Patient Problem Skin Irritation (2076)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the cr reviewed events preceding the event.After a successful trial implant, the patient had two freedom-8a stimulators implanted near the seventh and ninth thoracic vertebrae to treat chronic back pain on (b)(6) 2019.The cr confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, and the sterile barriers of all product used were intact prior to implant.The procedure was performed without complication, and the patient reporting receiving adequate pain relief.The cr reported that on (b)(6) 2020, the patient visited the physician due to itching and irritation near the implant site.Additionally, the patient reported to have attended several hospital and doctor visits for unrelated issues, such as upper respiratory and lung problems; the physician thinks that these conditions may have compromised immune response and contributed to the incident.The physician explanted both devices on (b)(6) 2020, without complication.The patient plans to have new stimulators implanted once the unrelated pre-existing health conditions subside.Skin irritation is known adverse event for spinal cord stimulation and is reduced as far as possible in stimwave's product's risk management file.Through a review of sterilization and packaging records for the respective lots, stimwave has confirmed that the products were delivered sterile, no trend of infection is evident for lot # swo181211 and swo190925, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The root cause of this event could not be attributed to the inability of the devices to meet physical, functional, performance and/or safety specifications.The physician believes the patient's pre-existing conditions and hospital visits may have potentially caused agitation contributed to the skin irritation.Corrective action is not required to remedy the root cause of the complaint, as the device did not fail to meet performance or safety specifications and no trend of skin irritation is evident for the sterilization lot.Stimwave has confirmed that the issue is a known adverse event, reduced as far as possible, and documented in stimwave's risk management files.Stimwave was in contact with the cr from march 20, 2020, onward regarding the complaint and the root cause investigation.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 explant was performed to preclude potential permanent tissue damage.

Event Description

Stimwave quality has investigated the details regarding skin irritation reported to stimwave on march 20, 2020, by clinical representative.

• Brand Name: FREEDOM-8A NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 9963779
• MDR Text Key: 198204520
• Report Number: 3010676138-2020-00038
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO181211, SWO190925
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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