MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM-8A SPINALL CORD STIMULATOR; SPINAL CORD STIMULATOR, PRODUCT CODE: GZB

Model Number FR8A-TRL-A0; FR8A-TRL-B0

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Following notification, stimwave quality and the territory manager reviewed events preceding the issue.Following a successful evaluation, the patient had a trial procedure performed on (b)(6) 2020, in which one (1) freedom-8a neurostimulator (fr8a-trl-a0; sn: (b)(4) and one (1) freedom-8a neurostimulator (fr8a-trl-b0; sn: (b)(4)) were implanted as a trial at the lower back.On (b)(6) 2020, the patient reported being admitted to a (b)(6) hospital after experiencing abdominal pain.The patient was then transferred to (b)(6) hospital where the trial stimulators were confirmed to be in place.The hospital's test results were inconclusive for the abdominal pain reported by the patient.Patient was released from (b)(6) hospital on (b)(6) 2020, and referred back to the trial clinician.On january 17, 2020, trial clinician reported to the territory manager that the patient was referred in to have the trial stimulators removed.The trial clinician was unable to locate the trial stimulators and was under the impression that the hospitals may has removed the trial stimulators while the patient was admitted.Trial clinician requested information from the hospital to determine if the hospitals had removed the trial stimulators.Trial clinician told territory manager that an x-ray could not be performed as the c-arm of his x-ray needed repairs.Patient was sent home until the x-ray c-arm could be repaired and the hospital's records could be received.On (b)(6) 2020, territory manager was able to confirm that the trial stimulators had migrated into the upper thoracic and cervical space.Implanting clinician scheduled the patient to a neurosurgeon for explant procedure to be conducted on (b)(6) 2020.On (b)(6) 2020, patient had both trial stimulators removed.A complication arose that required a laminotomy to be performed on the upper thoracic spine by the neurosurgeon in order to explant the trial stimulators that had migrated.The patient was kept in the hospital overnight for observation prior to being released.Patient is scheduled for a post op appointment with the neurosurgeon and implanting clinician on (b)(6) 2020 to ensure patient is doing well with no further complications.Stimulator migration is a known adverse event for spinal 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 of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause of this event is due to the trial stimulators having a higher risk of migration due to the inability to anchor as is done with permanent stimulators.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 january 17, 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 abdominal pain reported to stimwave on january 17, 2020, by territory manager.

• Brand Name: FREEDOM-8A SPINALL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR, PRODUCT CODE: GZB
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach, fl
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach, fl
• Manufacturer Contact: mary ann greenawalt ; 1310 park central boulevard s.; pompano beach, fl ; 9655134
• MDR Report Key: 9711091
• MDR Text Key: 194935627
• Report Number: 3010676138-2020-00013
• Device Sequence Number: 1
• Product Code: GZB
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Model Number: FR8A-TRL-A0; FR8A-TRL-B0
• Device Lot Number: SWO191212; SWO191212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2019
• 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