MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM-8A SPINAL CORD STIMUATOR; SPINAL CORD STIMULATOR

Model Number FR8A-RCV-A0

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Following notification, stimwave quality and the territory manager reviewed events preceding the issue.Following a successful trial, the patient had a permanent procedure performed on (b)(6) 2019, in which one (1) freedom-8a neurostimulator (fr8a-rcv-a0; sn: (b)(4)) was implanted in the scalp behind the ear.This implant was off label as the freedom-8a stimulator is intended to only be implanted below the neck.The territory manager was present at the time of the implant procedure.On (b)(6) 2020, the clinician contacted the territory manager to report erosion, skin irritation and tissue damage on the scalp behind the ear.This was discovered by the clinician during a routine follow up.The electrode end (farthest of the device was protruding from the skin (erosion), which was on the far side end of the incision site.The clinician scheduled the patient for an explant procedure on (b)(6) 2020.This was the opposite end of the incision site.On (b)(6) 2020, patient met with the clinician, who determined that surgical intervention (explant) was required.The implanting physician did not prescribed antibiotics to reduce the potential of infection as the patient was elderly.At this time ((b)(6) 2020), the patient is reported to be recovering without any further complications from this device explant.Stimulator migration is a known adverse event for peripheral nerve stimulators that are reduced as far as possible in the product's risk management file.The device did not fail to perform its essential functions.The root cause is due to the device being used at an off-label site and being implanted under the thin skin of the scalp.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known adverse event, reduced as far as possible, and documented in the stimwave risk management file.Stimwave was in contact with the territory manager from (b)(6) 2020, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to reduce migration, and that the product did not fail to meet performance and safety specifications.Stimwave has informed all parties that the product was not the source issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable, as the event required medical or surgical intervention to prevent or preclude permanent impairment or damage.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from device migration with skin irritation reported to stimwave on (b)(6) 2020, by territory manager.

• Brand Name: FREEDOM-8A SPINAL CORD STIMUATOR
• Type of Device: SPINAL CORD 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: mary ann greenawalt ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9683921
• MDR Text Key: 192400273
• Report Number: 3010676138-2020-00009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: 010081822502069317201201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO181211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2018
• 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