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

Model Number FR8A-RCV-A0

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

Patient Problems Shaking/Tremors (2515); Cognitive Changes (2551)

Event Date 12/22/2021

Event Type  Injury  

Event Description

The patient reported feeling shaking in their hands and difficulty with slurred speech.The patient was instructed to go to the emergency room.The implanting clinician and primary care physician determined the symptoms experienced by the patient were likely due to a narcotic allergy.The patient was instructed to stop taking the narcotic medication and is currently doing fine and receiving therapy from the stimulator.

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, the incident occurring before the implant of the device, and implanting the stimulator too close to the targeted nerve have been ruled out as potential causes of the reported issue.The provided information does not evidence that the stimwave device contributed to the issue.The stimulator is used to treat pain.The cause of the reported issue is unknown.Therefore, conclusion has been selected as no problem/fault found.

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 13357980
• MDR Text Key: 284507599
• Report Number: 3010676138-2022-00008
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: 010081822502069317221201
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO201216A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2021
• 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