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

Model Number PDBT-915-2K

Device Problem Electrical Shorting (2926)

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

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Stimwave dissembled the waa and connected the mfs board externally to our test equipment.The mfs board is fully functional and 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, making 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; excessive force was likely used (user error) when connecting the usb for this failure mode to occur.

Event Description

During the complaint investigation on (b)(6) 2020 of complaint (b)(4) for the wearable antenna assembly (waa), the usb connector appeared to be melted due to a short circuit.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach 33064
• MDR Report Key: 10840427
• MDR Text Key: 218521688
• Report Number: 3010676138-2020-00160
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020150
• UDI-Public: 0100818225020150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: 00255
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Date Device Manufactured: 09/27/2019
• 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): Required Intervention