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

Model Number PDBT-915-2K

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 07/11/2022

Event Type  Injury  

Event Description

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

Manufacturer Narrative

The reported issue could not be replicated.However, the investigation found the power amplifier was damaged.Due to the damaged power amplifier, the battery may feel warm while charging.The waa is unable to provide therapy while charging; the patient would not be using the unit at this time.Additionally, the programming parameters reported (0 off, 1 second on - continuous) may have contributed to the device becoming warm when operating.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: 28.3°c.Outside thermal temperature while charging: 30.6°c.Internal thermal temperature while operating: 28.4°c.The outside thermal temperature while charging was 30.6°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.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in blown power amplifier.Blown power amplifier rates remain acceptably low; thus, capa is not required.Blown power amplifier rates will continue to be tracked and trended.

• 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: 15191567
• MDR Text Key: 297514709
• Report Number: 3010676138-2022-00100
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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: 00635-ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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