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

Model Number FR8A-SPR-B0

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

Patient Problems Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint originating in (b)(6) resulting from apparent sacral stimulator migration reported to stimwave on june 25, 2018, by stimwave therapy specialist.A patient was implanted on (b)(6) 2018 with two (2) freedom-8 (fr8a-rcv-a0 and fr8a-rcv-b0) stimulators in the sacral region of the spine for pelvic pain.There were no complications during the procedure, and the patient was receiving at least 50% pain relief.The patient contacted the implanting clinician on (b)(6) 2018 with complaints of hip pain.An x-ray confirmed migration of the fr8a-rcv-b0 stimulator, at which time, the implanting clinician retrieved, repositioned, and secured both stimulators by tying together the distal ends of the stimulators with sutures.Approximately two (2) months later ((b)(6) 2018), the patient contacted the implanting clinician and informed that she was no longer receiving therapy and was experiencing hip pain.A second x-ray confirmed that the fr8a-rcv-b0 stimulator had migrated into the epidural space of the thoracic region.The implanting clinician determined that he would be unable to retrieve the migrated stimulator; a neurosurgeon was contacted to complete a laminectomy for device retrieval.The date of the laminectomy is unknown.Immediately following notification, stimwave quality reviewed the procedure with the therapy specialist.The therapy specialist informed stimwave quality of the following regarding the implanting clinician: the therapy specialist did not recommend the stimwave freedom scs system for this indication because the trial stimulator (implanted for seven (7) days on (b)(6) 2018) showed evidence migration out of the sacral hiatus.Rather, the therapy specialist communicated that another company's system would be best for implanting via the sacral hiatus, as the freedom scs system instructions for use does not include this procedure.The implanting clinician does not use anchors, as he believes they are a source of discomfort and scarring in younger patients.The implanting clinician is not comfortable with surgery; the therapy specialist made this observation while supporting the trial and permanent case in which the implanting clinician's sutures came undone on the table, and aversion to making a subcutaneous receiver pocket.For the (b)(6) 2018 migration, the implanting clinician was able to retrieve the stimulator because the end of the stimulator was tied into a knot.To reposition and re-tunnel the stimulator, the implanting clinician had to cut the knot out of the stimulator (exact length cut is unknown).The implanting clinician sutured the migrated stimulator to the stationary stimulator together as tightly as he could rather than using anchor.The patient informed the implanting clinician that they had resumed normal exercise following the implant procedure.The freedom scs system is not indicated for pelvic pain, thus the implanting clinician used the product off label.The freedom scs system includes an anchor component that was not implanted due to clinician preference.These two factors contributed to the migration that requires a laminectomy for device retrieval.It is possible that the patient's activity level may have also contributed to the migration, but an anchor would have prevented device removal with a laminectomy.The device did not malfunction or operate outside the specification parameters.While securing an anchor to the device and the surrounding tissue, or applying sutures directly to the device and the surrounding tissue mitigates stimulator migration, the implanting clinician elected not to use an anchor and demonstrated ineffective suturing.The root cause of the complaint is attributed to clinician practice, clinician inexperience, and patient selection.The implanting clinician elected not to use an anchor in conjunction with the stimulator to secure its placement and mitigate migration, even after the mild migration of the trial stimulator.The implanting clinician was aware that the patient is very active physically and may not be a good candidate for the product.Additionally, as suggested by the implanting clinician, the patient's resuming physical activity too quickly following the implant procedure may have contributed to the stimulator migration.This is the second complaint of stimulator migration with laminectomy explantation.As preventative measures through the use of an anchor has been established industry-wide, capa is not required to respond to or remedy the root cause of this complaint.The device did not malfunction or operate outside the specification parameters.Stimwave has also designed a deployable anchoring system (sandshark injectable anchor (sia) system), which is in review in (b)(6) with tga for market approval, and cleared for marketing in the united states by the fda and approved for marketing in the european union.The sia system eliminates the need to rely on clinician experience for preventing migration.Performance bench testing with this device demonstrates that the sandshark anchor further reduces occurrence of migration.Since market introduction in 2017, no migrations have been reported in the united states and europe.Stimwave was in constant contact with the clinical specialist beginning on june 25, 2018, regarding the complaint and the root cause investigation.Stimwave confirmed that the stimulator migration was not resultant of the device failing to meet performance or safety specifications.The migration could have been mitigated had the stimulator been implanted in conjunction with an anchoring system.In compliance with medical device reporting requirements and responsibilities, stimwave has reported this complaint as an adverse event to tga on july 2, 2018 and the fda on july 9, 2018.

Event Description

A patient was implanted on (b)(6) 2018 with two (2) freedom-8 (fr8a-rcv-a0 and fr8a-rcv-b0) stimulators in the sacral region of the spine for pelvic pain.There were no complications during the procedure, and the patient was receiving at least 50% pain relief.The patient contacted the implanting clinician on (b)(6) 2018 with complaints of hip pain.An x-ray confirmed migration of the fr8a-rcv-b0 stimulator, at which time, the implanting clinician retrieved, repositioned, and secured both stimulators by tying together the distal ends of the stimulators with sutures.Approximately two (2) months later ((b)(6) 2018), the patient contacted the implanting clinician and informed that she was no longer receiving therapy and was experiencing hip pain.A second x-ray confirmed that the fr8a-rcv-b0 stimulator had migrated into the epidural space of the thoracic region.The implanting clinician determined that he would be unable to retrieve the migrated stimulator; a neurosurgeon was contacted to complete a laminectomy for device retrieval.The date of the laminectomy is unknown.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTE,
• 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: 7671341
• MDR Text Key: 113472511
• Report Number: 3010676138-2018-00009
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004905
• UDI-Public: (01)00859619004905(17)191201
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO171206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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