MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; WEARABLE ANTENNA ASSEMBLY

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The reported issue of melting could not be replicated.Attempted worst case scenarios with alternate chargers and high voltage could not cause the same component damage.The investigation was concluded as no fault found, as investigation found the device did not have defect in regards to design or assembly.User error was unable to be confirmed, as the charger cable could not be obtained from the end user.The device is non-functional.Therefore, unable to retrieve software version and operating time.The investigation found the usb connector was damaged.There is evidence of exposure to excessive temperature at the usb connector.No indication of excessive temperature inside the unit beyond the usb connector.In addition, the investigation found the unit board was damaged by liquid ingress and will not power on.This attributed to pcb failure due to liquid damage.Attached to the report is a picture that shows the presence of liquid on the board.The investigation also found a damaged component - inductor l12 ferrite body cracked.Furthermore, the investigation found a cracked solder joint for rf sma connector.Pa device impedance verified to be normal.The charging cables were not available for analysis.

Event Description

The patient reported their wearable antenna assembly was left on the charger over night and melted.

• Brand Name: FREEDOM NEUROSTIMULATOR
• 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: 12693936
• MDR Text Key: 280581682
• Report Number: 3010676138-2021-00217
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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