MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR; WEARABLE ANTENNA ASSEMBLY

Model Number PDBT-915-2K

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

Patient Problem Burning Sensation (2146)

Event Date 11/23/2022

Event Type  Injury  

Event Description

The patient reported their wearable antenna assembly was overheating and causing a burning sensation to the skin.The overheating did not cause tissue damage or require medical intervention.The patient was provided a replacement waa.

Manufacturer Narrative

Investigation of the device was unable to replicate the alleged issue, and no nonconformances were found.However, the active setting is surge mode rf rate 500hz, pulse width 800 us.Refer to report # 06-02765 - tr-pdbt-2-programing depletion testing as the average operating time is 8.59 hours.For the report of overheating: thermal imaging was used to verify the outside temperature of the device while operating, outside temperature while charging, and the internal temperature while operating.Results are as follows: outside thermal temperature while operating: 30.2°c, outside thermal temperature while charging: 31.2°c, internal thermal temperature while operating: 31.3°c.The outside thermal temperature while charging was 31.2°c, which is below the product requirements specification of 41°c (106°f).Based on the thermal imaging, there is no evidence of thermal damage and the product met temperature specifications.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Type of Device: WEARABLE ANTENNA ASSEMBLY
• 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: 16018145
• MDR Text Key: 305914462
• Report Number: 3010676138-2022-00153
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00646-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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