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

Model Number FR8A-TRL-A0, FR8A-TRL-B0

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

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The patient stated he has been compliant with antibiotics, and the rash seems to be improving.The investigation did not present evidence that the product did not meet specifications, and the stimulator is being used to treat pain.The cause of the irritation is unknown/no problem found.The clinical representative 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 products used were intact before the implant.

Event Description

The implanting clinician observed that the patient's skin was red with a rash and elected to prescribe antibiotics (type, dosage, duration unknown).On (b)(6) 2020, the clinical representative followed up with the patient on the condition.

• 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: 10716074
• MDR Text Key: 212456714
• Report Number: 3010676138-2020-00080
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• 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: 09/09/2020

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: 05/01/2022
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO200528, SWO200605
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• 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