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

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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

The implanting clinician examined the patient on (b)(6) 2020, identified potential infection, and prescribed antibiotics to the patient (type, dosage, duration unknown).The implanting clinician explanted the device on (b)(6) 2020, to prevent the infection from spreading.The implanting clinician stated to the stimwave clinical representative that the patient is prone to infections due to the patient being thin and not having adequate fatty tissue to act as a barrier between the coil and the skin.The explant procedure was conducted successfully without complication.The stimwave 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.A review of sterilization and packaging records for the respective product lot swo200209 was performed: 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 infection was confirmed/replicated.There is no evidence that the product did not meet specifications.The stimulator is used for the treatment of pain.The cause of the infection is unknown/no problem found.

Event Description

On (b)(6) 2020, the patient reported feeling discomfort at the pocket/coil site and noticed the area had become inflamed and red.

• Brand Name: STIMWAVE 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: 11203106
• MDR Text Key: 227815999
• Report Number: 3010676138-2020-00190
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO200209, SWO200209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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
• Patient Age: 70 YR
• Patient Weight: 48