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

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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

On september 25, 2020 cr reported patient underwent 1.5 tesla mri on (b)(6) 2002.During the mri, patient experienced new pain in lower back.Mri was aborted.Patient does not report the pain since mri was stopped.On october 1, 2020, complaint specialist contacted cmo to set up time to discuss event with cr to determine a path forward.The stimulator was reported to meet product specifications.Device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.Cause of the sensation during mri could not be determined with the available information.

Event Description

On september 24, 2020 cr reported that the patient underwent a 1.5 tesla lumbar mri following stimwave ifu.During the mri, the device was turned off.Patient experienced pain/sensation in bilateral back.The mri was aborted.The patient no longer felt the unwanted pain and has not experienced it since.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach 33064
• MDR Report Key: 10731590
• MDR Text Key: 216604966
• Report Number: 3010676138-2020-00155
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2020

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: 11/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO191103, SWO191113
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• 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