MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

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

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

Patient Problem Seizures (2063)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint from a patient reported to stimwave business development manager.On (b)(6) 2019, the patient told the business development manager that she has been experiencing seizures and believed that they were attributed to her freedom spinal cord stimulator (scs) system.Immediately following notification, stimwave quality contacted the business development manager and the patient's implanting clinician to discuss the events leading up to awareness of the issue.The business development manager reported that the patient had relocated making travel to the clinician no longer feasible.The business development manager recounted that the patient stated that she was treated at an emergency room (dates and location are unknown and undisclosed) for her seizures.The implanting clinician informed stimwave that the patient's permanent system was implanted in 2017 and the patient was compliant with the therapy for her chronic arm pain.The implanting clinician was not aware that the patient relocated, and stated that the last appointment with the patient was (b)(6) 2018.At that appointment, the patient expressed interest in reducing her methadone dosage because the therapy from the freedom scs system was covering her pain.Upon notification of the patient's issue and her belief that the source of seizures could be related to her implant, stimwave's chief medical officer attempted to contact the patient to assist with identifying local clinical care for her, but the patient was nonresponsive to telephone calls.Stimwave representatives also attempted to contact the patient several times since (b)(6) 2019, but was unsuccessful at establishing communication or dialogue with the patient.The last date of attempted communication was march 12, 2019.It is unknown if the patient is continuing to use the freedom scs system, when the seizures began, if the device has been explanted, or the extent of care provided.The implanting clinician was not aware of any history or complaints of seizures while the patient was in his care.The effects of spinal cord stimulation have been studied to treat epileptic seizures: spinal cord stimulation has been used in complex pain surgery cases.The most accepted mechanism of action is "gate control theory" where stimulation of large myelinated fibers depresses impulse progression in nociceptive thin unmyelinated fibers (burchiel et al., 1996).Other possible mechanisms are primary afferent antidromic activation, inhibition of sympathetic activity, release of vasoactive substances and induction of supraspinal pathways (tubbs et al., 2005).This mechanism can also explain the suppression of epileptic cortical discharges with cervical scs in the results we present here.To our knowledge, this is the first literature report to demonstrate the effect of cervical scs on rat cortical epileptic discharges.All intensities of scs decreased penicillin-induced median values of epileptic discharge.Epileptic wave frequencies decreased significantly with increasing scs intensity.The results of this study suggest that scs may be a future alternative treatment modal for drug resistant epilepsy.Further research study is required to determine the usefulness of scs to treat other forms of epilepsy.Reference: ozcelik, levent, acar, feridun, cirak, bayram, et al.The influence of cervical spinal cord stimulation on induced epileptic discharges in rats.Brain research.2007; 1135 (1): 201-205.Doi: 10.1016/j.Brainres.2006.11.086.Seizure is not a known adverse event for spinal cord nerve stimulators.Stimwave is unable to locate any published literature, case studies, or adverse event reports suggesting that spinal cord stimulator could cause seizures.Stimwave is unable to confirm the correlation of the use of the freedom scs system and the onset of the patient's reported seizures.At this time, given the lack of communication with the patient, and without knowing the patient's medical history, stimwave is unable to trace the source of the issue the device or the procedure.Additionally, there exists evidence that spinal cord stimulation can be effective at treating seizures.The device did not fail to meet performance or safety specifications.Stimwave will continue to track and trend events.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, nor nonconformance to physical or functional device specifications.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.While seizures are not included as a possible adverse event for the freedom scs system, this is the first reported complaint of seizures, and stimwave will track and trend this complaint.Published scientific literature demonstrates that spinal cord stimulation can be effective at treating seizure.Stimwave was in constant contact with the business development manager, implanting clinician, and chief medical officer from (b)(6) 2019, onward regarding the complaint and the root cause investigation.At this time, the source of the issue does not appear to be device related.Stimwave remains in communication with all parties, as additional attempts to establish communication with the patient are ongoing.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 seizures can lead to an injury, and medical or surgical intervention was required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event.

Event Description

Stimwave quality has investigated the details surrounding a complaint from a patient reported to stimwave business development manager.On (b)(6) 2019, the patient told the business development manager that she has been experiencing seizures and believed that they were attributed to her freedom spinal cord stimulator (scs) system.The effects of spinal cord stimulation have been studied to treat epileptic seizures: spinal cord stimulation has been used in complex pain surgery cases.The most accepted mechanism of action is "gate control theory" where stimulation of large myelinated fibers depresses impulse progression in nociceptive thin unmyelinated fibers (burchiel et al., 1996).Other possible mechanisms are primary afferent antidromic activation, inhibition of sympathetic activity, release of vasoactive substances and induction of supraspinal pathways (tubbs et al., 2005).This mechanism can also explain the suppression of epileptic cortical discharges with cervical scs in the results we present here.To our knowledge, this is the first literature report to demonstrate the effect of cervical scs on rat cortical epileptic discharges.All intensities of scs decreased penicillin-induced median values of epileptic discharge.Epileptic wave frequencies decreased significantly with increasing scs intensity.The results of this study suggest that scs may be a future alternative treatment modal for drug resistant epilepsy.Further research study is required to determine the usefulness of scs to treat other forms of epilepsy.Reference: ozcelik, levent, acar, feridun, cirak, bayram, et al.The influence of cervical spinal cord stimulation on induced epileptic discharges in rats.Brain research.2007; 1135 (1): 201-205.Doi: 10.1016/j.Brainres.2006.11.086.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• 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: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 8420516
• MDR Text Key: 138795127
• Report Number: 3010676138-2019-00015
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004905
• UDI-Public: (01)00859619004905(17)190701(01)00859619004905(17)190701(21)206366-35
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2019
• Device Model Number: FR8A-RCV-A0;FR8A-SPR-B0
• Device Lot Number: SWO170630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2019
• Device Age: 19 MO
• Event Location: Home
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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