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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Numbness (2415)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

The patient described pain irradiating to the hands and could not hold a pen, use a fork or a knife.The clinical representative instructed the patient to contact the implanting clinician to report the occurrence.On (b)(6) 2021, the patient followed up with the implanting clinician on the event.On this date, the implanting clinician decided to explain the trial lead since the patient's discomfort had worsened.The implanting clinician instructed the patient to go to the emergency room to obtain further care on the condition.The implanting clinician confirmed the trial stimulator did not migrate.The clinical representative asked the implanting clinician if he knew the reason for the occurrence, and the implanting clinician stated no.Stimwave quality attempted to obtain more information on the reported issue with the clinical representative.However, no additional information was obtained.Based on this information, the discomfort experienced was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the discomfort unknown/no problem found.Risk document design fmea for (b)(4) and hra for (b)(4) was reviewed and discomfort/overstimulation is a known issue with mitigation controls in place to reduce risk as far as possible and no corrective action is required.Per previous investigations conducted for the same reported issue, the following are potential causes of the event: placement of stimulator too near to the nerve.Not following ifu during activation of stimulator.Improper waa programming parameters.The discomfort sensation felt by the patient could be electrical sensation/paraesthesia.Stimulator migration.

Event Description

On (b)(6) 2021, a patient recently implanted with a cervical trial stimulator contacted the clinical representative describing that the patient's whole body was numb and uncomfortable pain.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NEUROSTIMULATOR
• 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: 11720228
• MDR Text Key: 250269879
• Report Number: 3010676138-2021-00077
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• 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): Required Intervention