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

Model Number FR8A-TRL-B0, FR8A-TRL-A0

Device Problem Migration (4003)

Patient Problem Burning Sensation (2146)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Patient reporting a burning sensation caused by the patient's wife removing the dressing from the incision wounds.The implanting clinician confirmed migration had occurred.The trial leads were removed on (b)(6) 2021.The patient was monitored at the hospital following the removal of the explant to ensure infection was not present.The patient was discharged on (b)(6) 2021.No further issues have been reported.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, implanting an expired device, not using antibiotics, and the patient having pre-existing conditions have been ruled out as potential causes.However, the questionnaire shows the clinical representative is unsure of how the skin was prepared if multiple tunneling passes were required.In addition, it was reported the patient's wife removed both the sterile dressings and steri-strips used to affix the lead to the skin, causing the migration.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the migration is likely due to non-compliance to the ifu (user error - patient).

Event Description

Patient experienced a burning sensation at incision site and migration.Implanted neurostimulator was explanted as a result.

• 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: 12278522
• MDR Text Key: 265125471
• Report Number: 3010676138-2021-00164
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO210112, SWO210112A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2021
• 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