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

Model Number FR8A-RCV-A0, FR8A-SPR0B0

Device Problem Vibration (1674)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

The patient confirmed no additional implants are present.Patient requested stimwave to contact the mri facility to discuss the settings used during the scan.The unintended stimulation questionnaire was reviewed for potential causes of the reported issue.Based on this review, updates to waa parameters and patient going through electrical discharge or been around other electro magnetic sources have been ruled out as potential causes.However, the questionnaire shows the clinical representative is unsure if the patient has experienced a fall or engaged in strenuous activities, but this cannot be confirmed to be related to the event.On july 16, 2021, stimwave quality contacted the mri facility to obtain more information related to the parameter settings used during the mri.Stimwave learned the mri was performed using the correct settings during the mri procedure.The stimulator is used to treat pain.The cause of the mri induced stimulation is unknown/no problem found.

Event Description

Patient reporting a vibrating sensation after undergoing an mri procedure.

• 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: 12215009
• MDR Text Key: 263079657
• Report Number: 3010676138-2021-00156
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR0B0
• Device Lot Number: SWO19022, SWO1909257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• 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): Other