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

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

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

Patient Problem Skin Irritation (2076)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

The cr 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 cr maintained contact with the patient following implant.On (b)(6) 2019, the complaint specialist documented the following: on (b)(6), the patient reported a skin irritation around the implant site to the territory manager.The patient visited the implanting clinician the same day for evaluation.The implanting clinician noticed the patient had a skin rash at the implant site and believed it was due to an irritation caused by the glue and bandages.The implanting clinician does not believe it is attributed to the device.The irritation was treated by the implanting clinician and the device remains implanted.The device is providing therapy to the patient and no other complications were reported.No further information was available for this issue.On august 5, 2020, complaint specialist, reviewed sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of skin irritation is evident for swo190925, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulators were reported to meet product specifications.Device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.

Event Description

Stimwave quality has investigated the details for a report of skin irritation reported to stimwave on (b)(6) 2019, by clinical representative (cr), in the united states.Cr became aware of this issue on (b)(6) 2019.

• Brand Name: FREEDOM 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: 10419625
• MDR Text Key: 203861016
• Report Number: 3010676138-2020-00097
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO190925, SWO190925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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