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 Inflammation/ Irritation (4545)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, a final attempt was made with the cr to see if the patient's current condition was known.Cr stated contact with the patient had not been established to determine whether or not the patient did go to see physician in (b)(6) on (b)(6) 2020 the cr reported that the patient had still not been in contact with a physician due to the covid-19 crisis.On (b)(6) 2020 the cr reported that the patient had the stimulators explanted due to the skin not healing.On (b)(6) 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 loss of therapy is evident for swo191103 and swo190925, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator was reported to meet product specifications.Manufacturer cannot currently receive the stimulator for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.Based on this information, the skin not healing was confirmed/replicated and the cause of the skin not healing is unknown/no problem found.

Event Description

Stimwave quality has investigated the details for a report of skin irritation, submitted to the stimwave complaint system on (b)(6) 2020, by clinical representative (cr).

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach 33064
• MDR Report Key: 10756985
• MDR Text Key: 216826332
• Report Number: 3010676138-2020-00130
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO191103, SWO190925
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• 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