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

Model Number	FR8A-TRL-A0,FR8A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details surrounding a complaint resulting from an infection reported to stimwave on (b)(6) 2018, by stimwave clinical specialist.The patient had a trial procedure performed on (b)(6) 2018, in which two freedom-8a trial leads (fr8a-trl-a0 and fr8a-trl-b0) were implanted in the epidural space at the t8 to t9 level to treat the patient's low back and leg pain.During the procedure, the implanting clinician noted that the patient had some bleeding, but placing a suture resolved the issue.The implanting clinician was aware that the patient takes a baby aspirin daily as an over the counter blood thinner for a comorbidity.There were no other complications noted during the procedure.The patient experienced pain relief after the procedure and was sent home on antibiotics.At the end of the trial period, the patient reported significant pain relief with the device and his trial devices were removed on (b)(6) 2018.On (b)(6) 2018, the patient informed the implanting clinician that he started experiencing numbness and weakness in his legs.An mri evaluation (date is unknown to stimwave) revealed that the patient had fluid build-up in his epidural space.Concerned that the patient had a hematoma or seroma, the implanting clinician ordered immediate treatment through (b)(6) 2018 to resolve the issue.Treatment includes iv antibiotics.The patient is continuing treatment, and has reported that the weakness and numbness has subsided.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 the trial was performed in accordance with the product instructions for use.The implanting clinician was aware of the patient's aspirin regimen for his comorbidity at the time of the trial.It is likely that the adverse event occurred once the trials lead were removed, and the patient's comorbidity was an unanticipated complication following 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 patient's aspirin regimen for 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 (b)(6) 2018, 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 as a result of the patient's aspirin regimen for comorbidity.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 to the united states food and drug administration (fda) on (b)(6) 2018.
Event or Problem Description
The patient had a trial procedure performed on (b)(6) 2018, in which two (b)(6) were implanted in the epidural space at the t8 to t9 level to treat the patient's low back and leg pain.The implanting clinician was aware that the patient takes a baby aspirin daily as an over the counter blood thinner for a comorbidity.At the end of the trial period, the patient reported significant pain relief with the device and his trial devices were removed on (b)(6) 2018.On (b)(6) 2018, the patient informed the implanting clinician that he started experiencing numbness and weakness in his legs.An mri evaluation (date is unknown to stimwave) revealed that the patient had fluid build-up in his epidural space.Concerned that the patient had a hematoma or seroma, the implanting clinician ordered immediate treatment through (b)(6) 2018 to resolve the issue.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 8116833
• Report Number: 3010676138-2018-00015
• Device Sequence Number: 295628
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)200301(01)00818225020662(17)200301(21)207881-15
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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
• Operator of Device: Other
• Device Expiration Date: 03/01/2020
• Device Model Number: FR8A-TRL-A0,FR8A-TRL-B0
• Device Lot Number: SWO180322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 7 MO
• Event Location: Home
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention