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

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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, waa providing therapy when the unintended stimulation took place, and changing the waa parameters have been ruled out as potential causes of the reported issue.However, the questionnaire shows the patient has another device implanted which is not in compliance with the ifu.Clinical representative was able to confirm that the mri facility contacted stimwave to ensure mri compatibility settings.In addition, the waa was left outside the mri room.The stimulator is used to treat pain.The cause of the shock is likely due to interference from a non-stimwave device (user error - clinician).

Event Description

The patient reported feeling a shocking sensation while in the mri machine.The patient is not currently using the device and has an appointment scheduled with the implanting clinician to perform x-rays and define the treatment plan.

• 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: 12678384
• MDR Text Key: 277958125
• Report Number: 3010676138-2021-00216
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO200119, SWO191202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/22/2021
• 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): Required Intervention