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

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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Quality support reports shock/jolt during mri that was aborted.Mri technician indicated that patient had a prior implanted device that had been removed.Unintended stimulation questionnaire was reviewed for potential causes of the reported issue.Based on this review, mri induced stimulation occurred.Mri induced stimulation can be caused by migration, damaged stimulator, mri interference with stimulator(s), or magnetic field causing mechanical movement of the stimulator within the epidural space.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the mri induced stimulation is unknown/no problem found.

Event Description

Patient reported a shock down the right flank of her leg during the mri which was stopped immediately and no longer felt shock after it was stopped.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SOINAL 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: 12132688
• MDR Text Key: 260418430
• Report Number: 3010676138-2021-00144
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO190925, SWO190227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• 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