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

Model Number FR8A-RCV-A0; FR8A-SPR-B0

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

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Following notification, stimwave quality and the clinical representative reviewed events preceding the issue.Following a successful trial, the patient had a permanent procedure performed on (b)(6) 2019, in which one freedom-8a neurostimulator (fr8a-rcv-a0) was implanted on the top of the t8 vertebrae and one freedom-8a neurostimulator (fr8a-spr-b0) was implanted on the top of the t9 vertebrae in the thoracic region of the spine to relieve neuropathic pain.The clinical representative 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 completed without complication and patient was released on the same day following the procedure.On (b)(6) 2020, patient met with implanting clinician to discuss a lesion that originated from the top right incision not healing.The wound remains swollen, raised, tender, and painful when touched.Implanting clinician referred the patient to a wound care specialist to get further treatment of the wound.Implanting clinician did not observe any signs of infection at this appointment and had previously swabbed for infection on (b)(6) 2019.Swabs were negative for growth and infection was ruled out.On (b)(6) 2020, patient met with a wound care specialist concerning the lesion from the incision.Wound care specialist believed that the tissue was not healing due to the patient being thin.Wound care specialist also stated that new tissue was forming but the wound keeps opening.After this visit, the patient is considering and explant due to the lesion not healing.Skin irritation is known adverse event for spinal cord stimulation that is reduced as far as possible in the product's risk management file.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 lot swo191002 and swo190925, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The root cause, based on comments from the wound care specialist, is due to the patient being thin and the wound continuing to open while healing.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 clinical representative from february 24, 2020, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to reduce migration, and that the product did not fail to meet performance and safety specifications.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 may have caused or contributed to an injury and required medical intervention to prevent or preclude permanent impairment or damage.

Event Description

Stimwave quality has investigated the details regarding a potential skin irritation reported to stimwave on february 24, 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: mary ann greenawalt ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 9881525
• MDR Text Key: 196838075
• Report Number: 3010676138-2020-00029
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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; FR8A-SPR-B0
• Device Lot Number: SWO191002; SWO190925
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 61