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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

The stimulator is used to treat pain.Shock/jolt during mri can be caused by migration, magnetic field causing mechanical movement of the stimulator within the epidural space, magnetic field interacting with other implants, and/or the mri facility not following the instructions for use (ifu).Stimwave was unable to confirm mri conditions after attempts contacting the mri facilities.See support ticket-523 for (b)(6) health to obtain mri conditions for this case.X-rays were not available.Patient reported having implanted post-surgical hardware (pins, rods, screws, plates, wires) pins & screws.In the ifu 05-20400 rev.1, preparation for an mri line 2 states: "2.Do not conduct an mri procedure if the patient has any other implant or health condition that prohibits or contraindicates an mri examination.If the patient has another implant, especially an electronically activated or "active" device, the safety of performing an mri with the addition of freedom-8a neurostimulator is unknown." it is unknown whether the implanted post-surgical hardware (pins, rods, screws, plates, wires) pins & screws are mri compatible; this component may have contributed to the adverse mri reaction.The cause of the shock/jolt during mri has is likely attributed to the patient having other implants that are a contraindication per the device ifu.The investigation is inconclusive (no fault found), as there is not adequate information available to determine cause.

Event Description

Patient reports shock/jolt during mri, and the mri was aborted.Mri was scanning spine when sensation occurred.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NEUROSTIMULATOR
• 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: 11646554
• MDR Text Key: 245925168
• Report Number: 3010676138-2021-00065
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• 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