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 Problem Unspecified Infection (1930)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from a skin irritation, tissue damage, and infection reported to stimwave on (b)(6) 2019.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) freedom-8a receiver stimulator (fr8a-rcv-a0) and one (1) (fr8a-spr-b0) were implanted at the t8-t9 vertebral level.The territory manager 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 territory manager maintained contact with the patient following implant.On (b)(6) 2019, the patient contacted the territory manager to report skin irritation at the implant site.The patient was instructed to follow up with the implanting clinician for evaluation.On (b)(6) 2019, the patient visited the implanting clinician for follow up.The implanting clinician reported that redness and drainage was observed at the implant site.Cultures were taken; however, no results are available.The implanting clinician decided to explant the devices prophylactically.The explant procedure was performed on (b)(6) 2019.The explant procedure was performed without complications.It was reported that the patient is required to use a back brace due to patient comorbidities.The implanting clinician believes that the use of the back brace could have contaminated the wound and subsequently lead to the reported unconfirmed infection.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.Infection is a known adverse event for the freedom scs system (receiver instructions for use, 05-00629-6, page 14), and is detailed in stimwave's risk management file as well as applicable instructions for use and patient-facing labeling.Stimwave's global infection rate is <0.5%.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 of the issue is attributed to the patient's back brace which could have contaminated the implant wound.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.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in constant contact with the territory manager from (b)(6) 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance or safety specifications.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a skin irritation, tissue damage, and infection reported to stimwave on (b)(6) 2019.

• 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 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: 9298552
• MDR Text Key: 185188655
• Report Number: 3010676138-2019-00043
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201(01)00818225020693(17)200201(21)207611-86
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0
• Device Lot Number: SWO190202; SWO180215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2018
• 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