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 Fall (1848)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint originating from (b)(6) resultant from a migration, reported to stimwave on (b)(6) 2018 by stimwave clinical specialist.Following a successful trial with the freedom spinal cord stimulator (scs) system, the patient had a permanent procedure performed on (b)(6) 2018, in which a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0) was implanted in the patient's epidural space treat his chronic back pain.The receiver stimulator was inserted successfully up to body of t8; the excess was tunneled, and anchored per procedure.The spare lead could not be inserted past t10 due to scar tissue; the excess was tunneled, and anchored per procedure.There were no complications during the procedure, and the patient was receiving at least 50% pain relief.The patient returned to the clinic on (b)(6) 2018 and met with the implanting clinician for post-operative follow-up evaluation.At this appointment, the patient reported that he had fallen twice since the implant procedure.Stimwave has no information on what caused the patient to fall.The implanting clinician took x-rays, which revealed that the receiver stimulator had migrated to t5 and the spare lead migrated downward and anterior.The clinical specialist attempted to reprogram the devices to re-establish therapy.While the therapy was re-established, the implanting clinician determined it would be in the patient's best interest to explant the percutaneous devices and revision with paddle leads.The basis for this decision was risk that the patient may fall again, and if migration worsens, revision may be necessary in the future to re-establish therapy.Neither stimwave nor the clinical specialist has received any further information from clinic regarding the explant of the system.Immediately following notification, stimwave quality and management reviewed the implanting clinician's procedure compared to the receiver instructions for use with the clinical specialist.The clinical specialist states that the implanting clinician did comply with the product instructions for use with respect to securing the stimulator and anchoring the receiver.The source of the issue was not traced back to inadequate documentation of implant procedure, and the device did not fail to meet performance or safety specifications.Stimulator migration is a known adverse event for spinal cord stimulators and the freedom scs system and is mitigated as far as possible in the product's risk management file.Stimwave believes that impact of the patient's falls contributed to the migration of the devices.Given that only a few days had past from the implant procedure to the follow-up where the migration was noted, any jarring or significant impact a human body experiences affects the final position of a newly implanted device.For this reason, newly implanted patients are advised to refrain from strenuous activity to allow time for scar tissue to help stabilize the devices in the body in addition to anchoring techniques employed by implanting clinician.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 implanting clinician complied with procedures designed to mitigate migration.The root cause is attributed to unanticipated, jarring impact experienced as a result of the multiple patient falls.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 the issue is a known adverse event, 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 implanting clinician complied with the implant procedure to mitigate migration, and the product did not fail to meet performance and safety specifications.The source of the issue is attributed to unanticipated, jarring impact experienced as a result of the multiple patient falls.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 migration 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 (b)(4) therapeutic goods administration (tga) and the united states food and drug administration (fda) on december 3, 2018.

Event Description

Following a successful trial with the freedom spinal cord stimulator (scs) system, the patient had a permanent procedure performed on (b)(6) 2018, in which a freedom receiver stimulator (fr8a-rcv-a0) and spare lead (fr8a-spr-b0) was implanted in the patient's epidural space treat his chronic back pain.The receiver stimulator was inserted successfully up to body of t8; the excess was tunneled, and anchored per procedure.The spare lead could not be inserted past t10 due to scar tissue; the excess was tunneled, and anchored per procedure.There were no complications during the procedure, and the patient was receiving at least 50% pain relief.The patient returned to the clinic on (b)(6) 2018 and met with the implanting clinician for post-operative follow-up evaluation.At this appointment, the patient reported that he had fallen twice since the implant procedure.Stimwave has no information on what caused the patient to fall.The implanting clinician took x-rays, which revealed that the receiver stimulator had migrated to t5 and the spare lead migrated downward and anterior.The clinical specialist attempted to reprogram the devices to re-establish therapy.While the therapy was re-established, the implanting clinician determined it would be in the patient's best interest to explant the percutaneous devices and revision with paddle leads.The basis for this decision was risk that the patient may fall again, and if migration worsens, revision may be necessary in the future to re-establish therapy.Neither stimwave nor the clinical specialist has received any further information from clinic regarding the explant of the system.

• 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: 8125021
• MDR Text Key: 129153390
• Report Number: 3010676138-2018-00019
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191101(01)00859619004905(17)191201(21)207254-44
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171109,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: 11/27/2018
• Device Age: 1 YR
• Event Location: Home
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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