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

Device Problem Unintended Electrical Shock (4018)

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

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

The patient states having been implanted with an scs device, but serial/lot numbers were not provided.The clinical representative was not present for the implant procedure.Based on this information, the shock/jolt during mri was unable to be confirmed/replicated.There is no evidence that the product did not meet specifications, and 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 has confirmed proper mri conditions.X-rays were not available, but were mentioned during interview to show a remaining fractured piece of a previously used boston scientific tens unit that had been explanted.In the ifu 05-20400 rev.1, preparation for an mri line 2 states: 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 fractured piece of boston scientific tens unit is mri compatible; this component may have contributed to the adverse mri reaction.The cause of the shock/jolt during mri has not been attributed to the implanted stimwave device; therefore, the dhr was not reviewed.The investigation is inconclusive (no fault found), as there is not adequate information available to determine cause.Design fmea 06-0537 and hra 06-0524 were reviewed to confirm induced current from mri and overstimulation during mri are known issues with mitigation controls in place to reduce risk as far as possible.Thus, capa is not required.Stimwave's global mri adverse event rate is (b)(4), as of (b)(4) 2020.The frequency is rare and severity is critical.

Event Description

Patient reports pain and shock/jolt during mri, and the mri was aborted.

• 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: 11562607
• MDR Text Key: 255594759
• Report Number: 3010676138-2021-00052
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• 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: 02/22/2021
• 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