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

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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The patient stated that he had a follow-up with the primary care physician related to the skin irritation and the bump.On december 28, 2020, the patient followed-up with the implanting clinician.On this date, the implanting clinician performed imaging and determined that migration had occurred.On december 30, 2020, the implanting clinician performed a revision.The implanting clinician performed a small incision and trimmed the sandshark wing down.The physician also irrigated the site and stitched it shut with a double layer of sutures.There was no infection and no loss of therapy.However, antibiotics were prescribed as a preventative measure.The patient is doing well after the procedure and has a follow-up the week of january 8, 2020.Stimwave conducted a review of sterilization and packaging records for the respective product lot.Stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Based on this information, the migration/skin irritation were confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the migration/skin irritation is unknown/no problem found.A potential cause of the event may be device placement at inadequate depth too near to the skin.

Event Description

On december 28, 2020, the patient reached out to the implanting clinician and the clinical representative, reporting skin irritation and a bump under the skin.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NERVE 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11244921
• MDR Text Key: 229162069
• Report Number: 3010676138-2020-00179
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO190607, SWO190925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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): Congenital Anomaly; Required Intervention
• Patient Age: 71 YR