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

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

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

Patient Problem Hematoma (1884)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from hematoma reported to stimwave on january 16, 2019, by stimwave clinical specialist (b)(4).The patient had a trial procedure performed on (b)(6) 2019, in which two freedom-8a trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted in the epidural space at the c2 to c3 level to treat the patient's chronic arm and shoulder pain.The clinician was aware that the freedom scs system is indicated for low back and leg pain.There were no other complications noted during the procedure.The patient experienced pain relief after the trial and was sent home following recovery the same day.That evening, the patient contacted the clinical specialist with complaints of numbness in her arms and legs.The clinical specialist advised the patient to contact her clinician who in turn instructed her to seek treatment at a local emergency room.An mri evaluation revealed that the patient had fluid build-up in her epidural space.Concerned that the patient had a hematoma or seroma, the treating hospital ordered treatment through (b)(6) 2019 to resolve the issue.It is not known if the treatment includes iv antibiotics.The patient's trial device was explanted without complication at the hospital.There were no complications with the explant procedure.The patient is continuing treatment, and has reported that the numbness has subsided.The treating neurosurgeon at the hospital has confirmed that surgical intervention will not be necessary to treat the patient's condition.Immediately following notification, stimwave quality and management reviewed the implanting clinician's procedure compared to the trial instructions for use with the clinical specialist.The clinical specialist confirmed that while the procedure was off label, the trial was performed in accordance with the product instructions for use.The implanting clinician was not aware of any concomitant medication or comorbidities that would exclude her as a candidate for a spinal cord stimulator at the time of the trial.It is likely that the patient had comorbidity unknown to her and her clinician, and this adverse event was an unanticipated complication of the trial.Epidural hemorrhage, hematoma, or paralysis is a known adverse event for spinal cord stimulation and the freedom scs system, is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling and is mitigated as far as possible.While the implantation procedure may have contributed to the adverse event, the device did not fail to meet performance or safety specifications.Stimwave will continue to 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.The root cause is likely attributed to the trial procedure complicated by the unknown patient comorbidity.The stimwave product was not the source of the issue.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 epidural hemorrhage, hematoma, or paralysis is a known risk, mitigated as far as possible, and documented in the stimwave's risk management file.Stimwave was in constant contact with the clinical specialist starting january 16, 2019, regarding the complaint and the root cause investigation.Stimwave confirmed that the trial was performed according to the ifu, and the product did not fail to meet performance and safety specifications.The source of the issue is a known risk and is mitigated as far as possible.The adverse event was an unforeseen complication, likely a result of a unknown comorbidity to the patient and the implanting clinician.Stimwave has informed all parties that the product was not the source of the 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 hematoma or seroma 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

The patient had a trial procedure performed on (b)(6) 2019, in which two freedom-8a trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted in the epidural space at the c2 to c3 level to treat the patient's chronic arm and shoulder pain.The clinician was aware that the freedom scs system is indicated for low back and leg pain.There were no other complications noted during the procedure.The patient experienced pain relief after the trial and was sent home following recovery the same day.That evening, the patient contacted the clinical specialist with complaints of numbness in her arms and legs.The clinical specialist advised the patient to contact her clinician who in turn instructed her to seek treatment at a local emergency room.An mri evaluation revealed that the patient had fluid build-up in her epidural space.Concerned that the patient had a hematoma or seroma, the treating hospital ordered treatment through (b)(6) 2019 to resolve the issue.It is not known if the treatment includes iv antibiotics.The patient's trial device was explanted without complication at the hospital.There were no complications with the explant procedure.The patient is continuing treatment, and has reported that the numbness has subsided.The treating neurosurgeon at the hospital has confirmed that surgical intervention will not be necessary to treat the patient's condition.

• 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: 8279220
• MDR Text Key: 134138922
• Report Number: 3010676138-2019-00001
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)200201(01)00818225020662(17)201101(21)209564-15
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180981
• 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: 01/16/2019,01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: FR8A-TRL-A0;FR8A-TRL-B0
• Device Lot Number: SWO180206,SWO181113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Device Age: 11 WK
• Event Location: Home
• Date Report to Manufacturer: 01/16/2019
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2018
• 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): Hospitalization