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 05/06/2021

Event Type  Injury  

Manufacturer Narrative

The patient is currently doing well and is keeping the site clean to help with the healing of the infection.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, patient picking on the wound, not using antibiotics, not prepping the skin, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician stated that the cause of the infection was unknown.However, the questionnaire shows the incision site was not irrigated with antibiotics prior to closure by the implanting clinician, which is not in compliance with the ifu.The stimulator is used to treat pain.The cause of infection is due to lack of irrigation with antibiotics prior to closure and clinician user error.

Event Description

Patient is suffering from an infection which is being treated with antibiotics.The implanting clinician stated revision/explant not needed, and no further issues have been reported.

• 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: 11943976
• MDR Text Key: 254489035
• Report Number: 3010676138-2021-00113
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230101
• 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: 06/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• 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