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

Model Number PDBT-915-2K

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 02/06/2021

Event Type  Injury  

Manufacturer Narrative

The patient received two new waas, and the shocking sensation ceased.(b)(4), the investigation found no issue with the units and unable to replicate the alleged issue.The setting on the devices follows the parameter for surge mode consisting on rate 500 hz and width of 800 us.After the incident, the patient was provided with replacement devices programmed at the same parameters, and the issue did not recur.The device was verified to meet specification, and no root cause was found for the reported incident.Based on this information, the shock/jolt was not confirmed/replicated.The mild shock felt by the patient could be electrical sensation/parasthesia.Based on the stimulator investigation, there is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the shock/jolt is unknown; no problem found.Design fmea 06-0537 and hra 06-0524 was reviewed and painful and overstimulation due are known issues with mitigation controls in place to reduce risk as far as possible.

Event Description

On (b)(6) 2021, the patient-reported experiencing a shocking sensation so hard that it made the patient fall off the couch while activating the waa.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NERVE STIMULATOR
• 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11454342
• MDR Text Key: 248075844
• Report Number: 3010676138-2021-00035
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 00396-D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other