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 Problems Pain (1994); Electric Shock (2554)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Mri was scanning spine when sensation occurred.Mri scanned the 8th and 9th thoracic vertebrae, which is where both stimulators are implanted.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, and/or magnetic field interacting with other non-stimwave implants.Stimwave has confirmed compliance of mri facility with the ifu.X-rays were not available.The cause of the shock/jolt during mri has is unknown/no problem found.The investigation is inconclusive (no fault found), as there is not adequate information available to determine cause.

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: 11703824
• MDR Text Key: 246672977
• Report Number: 3010676138-2021-00076
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO181211, SWO190222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• 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