MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM-8A SPINAL CORD STIMULATOR; SPINAL CORD STIMULATOR, PRODUCT CODE: GZB

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

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

Patient Problems Erosion (1750); Death (1802)

Event Date 01/15/2020

Event Type  Death  

Manufacturer Narrative

Immediately following notification, stimwave quality and the clinical representative reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a spinal cord stimulator (fr8a-rcv-a0; sn: (b)(4)) and one (1) freedom-8a spinal cord stimulator (fr8a-spr-b0; sn: (b)(4)) was implanted at the lower back.The clinical specialist confirmed that 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 clinical specialist maintained contact with the patient following implant.On (b)(6) 2020, clinician made contact with stimwave's clinical specialist.Clinician reported that on (b)(6) 2020, a revision was performed to address an erosion that caused skin irritation at the implant site.Clinician stated that the stimulator could be palpated (felt by touch).Clinician stated that on (b)(6) 2020, patient called the office to report continued pain at the implant site.The clinician was out of the office and was unable to schedule an appointment for (b)(6) 2020.On (b)(6) 2020, the patient's husband called the implanting clinician's office to report that the patient had passed away on saturday, (b)(6) 2020.The clinician reported that the autopsy revealed that the cause of death was due to a blood infection.On (b)(6) 2020, the implanting clinician contacted the clinical representative and stated that the incision site was clear of visual signs of infection.The clinician is not yet aware of the origin of the blood infection, and the investigation ongoing.On (b)(6) 2020, stimwave's chief medical officer (cmo) was in contact with the implanting clinician.Implanting clinician stated that the patient was an obese female and that the blood infection was, to his knowledge, not related to the implant.Patient had an allergy to nickel which was the justification for using stimwave's stimulator, over other similar product, as it does not contain nickel.Death certificate has not yet been released but the implanting clinician does not believe the stimulator did not cause or contribute to the death.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 swo191025 and swo191103, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Stimulator migration is a known adverse event for spinal cord stimulators that are reduced as far as possible in the product's risk management file.The root cause of the complaint could not be attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The root cause of the issue may be attributed to non-compliance, patient history, or the patient's predisposition to infections.The root cause is likely due to poor anchoring technique; however, investigation efforts could not confirm it.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 infection 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 january 20, 2020, onward regarding the complaint and the root cause investigation.Stimwave confirmed 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 resulted in injury that required medical intervention to preclude potential permanent impairment or damage.

Event Description

Stimwave quality has investigated the details regarding a complaint of a skin irritation/erosion, that may have contributed or caused death, reported to stimwave on (b)(6) 2020, by clinical representative.

• Brand Name: FREEDOM-8A SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR, PRODUCT CODE: GZB
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach, fl
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach, fl
• Manufacturer Contact: mary ann greenawalt ; 1310 park central boulevard s.; pompano beach, fl ; 9655134
• MDR Report Key: 9717688
• MDR Text Key: 179698571
• Report Number: 3010676138-2020-00014
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: FR8A-RCV-A0; FR8A-SPR-B0
• Device Lot Number: SWO191025; SWO191103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention