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

Model Number FR8A-SPR-B0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

The implanting clinician checked the incision where channel b was implanted, noticed, and identified that the incision did not seem to be healing well.The implanting clinician pointed out to the clinical representative that the patient seemed to be having the same issue as before.The implanting clinician had previously followed up with stimwave cmo when complaint-(b)(4) was reported.The cmo and the implanting clinician determined that the wound not healing might be related to a reaction to the silk stitches or pocket being too superficial.The implanting clinician performed a revision, and the incision healed well.The patient told the implanting clinician that excellent pain relief is being received and would hate to get the stimulator explanted.The implanting clinician and the clinical representative decided to test lead a on its own.The patient stated receiving great paresthesia on the left leg, where the patient typically has the most pain.On (b)(6) 2021, the implanting clinician decided to remove the lead b.The explant procedure was conducted successfully.The implanting clinician swapped the site and sent the sample for testing (results not available).The implanting clinician noted that the site did not look infected.However, wanted to get testing done.The patient was prescribed another round of antibiotics (dosage, name, frequency, unknown).The clinical representative confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant 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 wound not healing 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 wound, not healing is due to a reaction to the silk stitches or pocket being too superficial.

Event Description

On (b)(6) 2021, the patient attended a follow-up appointment with implanting clinician for a pocket revision.The implanting clinician inspected the pocket revision, and it seemed to be healing well.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINCAL 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: 11683260
• MDR Text Key: 245984758
• Report Number: 3010676138-2021-00073
• 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: 04/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2022
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO200604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• 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