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

Model Number FR8A-RCV-A0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

The clinical representative followed-up on the occurrence with the implanting clinician to gain more information.The implanting clinician stated that the patient had been admitted to the hospital to control the pain.On (b)(6) 2021, the clinical representative visited the patient at the hospital.On this date, the clinical representative learned that the implanting clinician had explanted the left lead (a-lead) on (b)(6) 2021.The clinical representative reprogrammed the b-lead, which was not explanted following the implanting clinician's parameters.The clinical representative reported that the patient was released from the hospital on (b)(6) 2021.The patient-reported that she was feeling better following the removal of the lead and the irritation is now in control.The patient also reported feeling relief after the reprogramming session.The clinical representative set 3 programs based on her tonic response and set it to program one.The clinical representative sat with the patient for 15 minutes after turning on program one, and the patient-reported good pain relief in the desired area.Clinical representative confirmed that the implant procedure was performed in a sterile environment with sterile field handling protocols, sterile barriers of all products used were intact before the implant, and the procedure was completed in accordance with the product instructions for use.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.Based on this information, the irritation/discomfort 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 irritation/discomfort is unknown/no problem found.Design (b)(4) were reviewed, and irritation and discomfort are known issues with mitigation controls in place to reduce risk as far as possible therefore, no capa is required.Stimwave's global new pain rate: (b)(4) stimwave's global skin irritation rate: (b)(4).

Event Description

On (b)(6) 2021, the clinical representative became aware that a recently implanted patient had been admitted to the hospital due to pain, irritation, and discomfort following the implant procedure.

• 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: 11543922
• MDR Text Key: 257278252
• Report Number: 3010676138-2021-00051
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: 010081822502069317211001
• 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: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO191025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2021
• 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