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

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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient experiencing a fall, engaging in strenuous activities, patient overextended or overexerted, causing the stimulator to move, changing the waa parameters intentionally/unintentionally, and the waa going through an electrical discharge or been around other electro-magnetic sources have been ruled out as potential causes.The implanting clinician stated the cause of the shock was migration.However, x-rays have not been taken to confirm migration.The electrical sensation could have been caused by high programming parameters and/or stimulator placement too near to the nerve.The stimulator is used to treat pain.The cause of the overstimulation is unknown/no fault found.

Event Description

The patient reported feeling a shock on two different occasions.The patient is requesting the device be explanted.However, the device has not been explanted as of yet and he patient was instructed to keep the therapy off.

• 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: 11985419
• MDR Text Key: 255906965
• Report Number: 3010676138-2021-00120
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-RVC-A0, FR8A-SPR-B0
• Device Lot Number: SWO190815, SWO197090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other