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

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

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem Weakness (2145)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint of right leg weakness resulting in explant of the device reported to stimwave on may 14, 2018 by a specialist in (b)(6).The patient was implanted on (b)(6) 2018 with a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0) for neuropathic leg pain.Before the permanent procedure, the patient successfully completed a 10-day trial with the freedom scs system trial leads.There were no complication experienced during the trial and the patient reported adequate pain relief and no issues or illness during this period.The patient followed up at a clinic on (b)(6) 2017 and reported no issues or illness.The patient was scheduled to receive a permanent system on (b)(6) 2018.Following implantation, and during recovery, the patient reported weakness in her right leg.Following a ct scan, the implanting clinician explanted the devices and referred the patient to a neurologist on (b)(6) 2018.The specialist was informed of the explant on (b)(6) 2018.Immediately following notification, stimwave quality reviewed the procedure with the specialist who reported on the findings of the implanting clinician.On implant day, the patient was put under general anesthesia for the duration of the procedures.This practice is not typically required for spinal cord stimulation implantation, but is a preferred method by the implanting clinician.The receiver stimulator was placed starting at l2 and was implanted without issue.Fluoroscopy images confirmed the accurate placement of the device.While the implanting clinician was placing the spare lead, lateral fluoroscopy images showed that the device was anterior, rather than posterior.The implanting clinician attempted two more times to adjust the placement of the spare lead to be posterior at the same level (l2) as the receiver stimulator.When these attempts failed, the implanting clinician determined it was clinically necessary to make a new incision at l1 for placing the spare lead.A lateral fluoroscopy image showed that the spare lead was posteriolateral, which was not ideal, but the implanting clinician determined that this placement was better than attempting to continue repositioning efforts.The implanting clinician closed the incisions and the patient was sent to recovery.At approximately 8pm on (b)(6) 2018, the patient reported that she was experiencing weakness in her right leg.The implanting clinician immediately ordered a ct scan that showed that the posteriolateral device was in a very tight lateral recess area where stenosis was present.Once identified, the implanting clinician determined that the patient should have both the receiver stimulator and the spare lead explanted.On (b)(6) 2018, a neurologist ordered an mri and determined the best treatment for the patient would be physical therapy.On (b)(6) 2018 the specialist followed up with the patient and the implanting clinician and reported that the patient should make a full recovery following physical therapy.The receiver stimulator and spare lead were not activated at any time on (b)(6) 2018, as the implanting clinician prefers to wait until the incision sites are healed before programming the devices.The ct scan post-implantation revealed a possible preexisting condition, spinal stenosis, may have contributed to the difficultly placing the spare lead.Additionally, the lateral recess area where the posteriolateral device was placed was likely pressing on a nerve, potentially causing or contributing the right leg weakness that the patient experienced following the permanent procedure.The clinician used only the accessories provided in the sterile kits, and did not note any indicator of the compressive forces on the surrounding nerves, but made calculated attempted to ensure that the devices were implanted with the least amount of trauma possible.At this time, stimwave has determined that while the implant procedure contributed to the issue, the patient's physiology and potential pre-existing condition (spinal stenosis) was an unforeseen complication that caused to the issue.The device did not fail to meet performance or safety specification, and the device was being used for treatment.This is the first reported case of weakness following an implant procedure.Stimwave will continue to trend events of this nature.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specification, and the device was being used for treatment.Stimwave has confirmed that clinician was not aware of the patient's spinal physiology prior to the implanting procedure and responded quickly and appropriately to prevent any permanent damage or harm to the patient.Stimwave has informed the specialist and the implanting clinician of the results of this investigation and its reportable nature.In compliance with medical device reporting requirements and responsibilities, stimwave has reported this as an adverse event to the (b)(6) and the united states food and drug administration (fda) on may 21, 2018.

Event Description

The adverse event occurred in (b)(6).The patient was implanted on (b)(6) 2018 with a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0) for neuropathic leg pain.Before the permanent procedure, the patient successfully completed a 10-day trial with the freedom scs system trial leads.There were no complication experienced during the trial and the patient reported adequate pain relief and no issues or illness during this period.The patient followed up at a clinic on (b)(6) 2017 and reported no issues or illness.The patient was scheduled to receive a permanent system on (b)(6) 2018.Following implantation, and during recovery, the patient reported weakness in her right leg.Following a ct scan, the implanting clinician explanted the devices and referred the patient to a neurologist on (b)(6) 2018.The specialist was informed of the explant on (b)(6) 2018.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INCORPORATED; 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: 7529896
• MDR Text Key: 108783687
• Report Number: 3010676138-2018-00006
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191001(01)00859619004905(17)121201(21)207255-73
• 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: 05/14/2018,05/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Catalogue Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Lot Number: SWO171024,SWO171206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2017
• 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