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

Model Number FR8A-SPR-B0

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

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

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

Patient reporting a possible infection with an explant procedure scheduled for (b)(6) 2021.No further issues have been reported.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, implanting an expired device, not prepping the skin, using inappropriate tools, patient engaging in strenuous activities, patient picking on the wound, and multiple tunneling attempts have been ruled out as potential causes.However, the surgical questionnaire shows the implanting clinician did not irrigate the site before closure, and did not prescribe antibiotics prior to the procedure, potentially contributing to the occurrence.In addition the questionnaire outlines the patient having pre-existing conditions related to psychological disorder and cardiovascular conditions.A stimwave representative 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.The stimulator is used to treat pain.The cause of the infection/tenderness is user error-clinician.

Event Description

Patient experienced infection at the incision site.

• 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: 12235623
• MDR Text Key: 263809709
• Report Number: 3010676138-2021-00159
• 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: Other
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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