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

Model Number FR8A-SPR-B0, FR8A-RCV-A0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Post Operative Wound Infection (2446)

Event Date 04/10/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the stimulators after the expiration date and not prepping the skin with antiseptic solution have been ruled out as potential causes of the reported issue.Correct tools were used, antibiotics were prescribed pre-operatively and post-operatively and the patient did not touch/pick the wound.The patient had a non-stimwave system previously implanted which was explanted due to pocket pain; the patient may have a history of slow/difficult wound healing, but this could not be confirmed with certainty.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 infection is unknown.Therefore, conclusion has been selected as no problem/fault found.

Event Description

On (b)(6) 2022 the patient was implanted with two freedom spinal cord nerve stimulators (serial number: (b)(4)) to treat chronic pain.On friday (b)(6) 2022 it was reported the wound was a little inflamed, but not noticeable.On saturday (b)(6) 2022 and sunday (b)(6) 2022 the patient had a fever, felt bad and had a wound infection.An emergency explant procedure was performed on sunday (b)(6) 2022.Antibiotics were prescribed before, during and after surgery.There was nothing noticeable around the wound prior to friday (b)(6) 2022.The explant procedure went smoothly and the patient is doing well.

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 14350528
• MDR Text Key: 291345367
• Report Number: 3010676138-2022-00062
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO210713, SWO200528
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• 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