MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR

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

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

Patient Problems Skin Erosion (2075); Skin Irritation (2076)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a receiver stimulator (fr8a-rcv-a0) and one (1) spare lead (fr8a-spr-b0) were implanted bilaterally at the thoracic nerve.The freedom scs system is not cleared for peripheral nerve stimulation by the therapeutic goods administration.However, the implanting clinician opted to continue with the implant by their own clinical judgement.The territory manager 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 the territory manager maintained contact with the patient following implant.On (b)(6) 2019, the patient contacted the territory manager to report irritation at the implant site.The patient reported the device was proximal to the surface of the skin and it was causing discomfort.The patient had imaging performed and confirmed the irritation was being cause by the devices that had moved closer to the surface of the skin.Further review of the patient's medical history demonstrated the patient's body is very twisted when walking, and it is likely this contributed to the patient's device moving towards the surface of the skin.The patient had a revision performed on (b)(6) 2019.The procedure was completed without complication.The root cause of the event is likely attributed to a combination of off-label placement of the device by the implanting clinician and patient physiology and movement.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a skin irritation reported to stimwave on (b)(6) 2019, by territory manager.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• 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: 10073286
• MDR Text Key: 195404701
• Report Number: 3010676138-2020-00056
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Lot Number: SWO180206,SWO171206
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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