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

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end of the cord where it goes into the waa charger was melted.The patient implant procedure was performed on (b)(6) 2020, and the patient was on day six (6) of the trial when this event took place.During the complaint investigation for the wearable antenna assembly, waa.The usb connector appeared to be melted due to a short circuit.We dissembled the waa and connected the mfs board externally to our test equipment.The mfs board was fully functional, and it draws the correct amount of current proving that the board did not cause the short circuit.After further evaluating the usb connector under a microscope it appears that the usb connector pins are melted including the guide shield.This suggests the user may have forced the usb connector incorrectly and the vb pin, which supplies current to the board, make contact with the guide shield or another signal pin causing a short circuit.Usb connectors are mistake proof with only one correct way to connect.There may have been excess force when connecting the usb for this failure mode to occur.Investigation also found the device's battery is expanded (battery l/n: 200408).The cause of expanded battery is attributed to material.A thermal image of the internal board of the waa.In addition, a thermal image of the assembled waa using the same charger but different usb cable since the one that came on the rma was (picture attached), the image near the charging area is blue, meaning it is cool, no highest temperature is 77.4 degrees f after 1 hour charging.Based on these images, there is no evidence of overheating due to the waa.Based on this information the waa overheating was not replicated/confirmed.The cause of the waa melted cord is user error.
Event or Problem Description
On (b)(6) 2020, the patient contacted the clinical representative to reported an electrical burn smell coming from the waa charger cord.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 11073286
• Report Number: 3010676138-2020-00184
• Device Sequence Number: 2683457
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: 010081822502067917220901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K1710141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/28/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO200922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Weight: 73