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 Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

On this date, the implanting clinician removed the trial leads and advised the patient to follow up at a local hospital to get an ultrasound to rule out a blood clot.The patient was sent home from the hospital after the ultrasound and was told no clots were present.At a follow-up appointment with the implanting clinician on september 8, 2020, the implanting clinician identified that the patient had developed cellulitis and prescribed oral antibiotic treatment (type, dosage, duration unknown).The clinical representative confirmed that the implant procedure was performed in a sterile environment with sterile field handling protocols, sterile barriers of all products used were intact before the implant, and the procedure was completed following the product instructions for use.Based on this information, the infection was 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 infection is unknown/no problem found.

Event Description

On (b)(6) 2020, the patient reported waking up feeling pain in his right leg.On this date, the patient made an appointment with the implanting clinician for follow-up.The implanting clinician examined the leg and observed swelling and pain to the touch.

• 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: 10657158
• MDR Text Key: 216393332
• Report Number: 3010676138-2020-00145
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO200314, SWO191024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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