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

Model Number FR8A-TRL-B0

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

Patient Problem Swelling/ Edema (4577)

Event Date 04/07/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 the patient was implanted with a trial spinal cord nerve stimulator in the epidural space.On (b)(6) 2022 the patient reported swelling in their left foot.Antibiotics were prescribed although an infection was not confirmed.An explant procedure was performed on (b)(6) 2022, and no further issues have been reported.

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting the stimulator too close to the targeted nerve, and migration have been ruled out as potential causes of the reported issue.The stimulator is used to treat pain.The cause of swelling is unknown.Therefore, conclusion has been selected as no problem/fault found.Note: complaint determined to be reportable upon notification of medical intervention (antibiotics prescribed).

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 14501500
• MDR Text Key: 292700203
• Report Number: 3010676138-2022-00069
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020662
• UDI-Public: 010081822502066217240101
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Model Number: FR8A-TRL-B0
• Device Lot Number: SWO220118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• 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