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

Model Number FR8A-SPR-B0

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

Patient Problem No Code Available (3191)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details surrounding a complaint resulting from an apparent stimulator fracture with clinician (b)(6), do and therapy specialist (b)(6) reported to stimwave on may 18, 2017.The stimulator will be explanted at the patient's request.The decision to explant the stimulator followed evidence that the device had fractured and migrated.However, this event did not result in any injury to the patient and therefore the clinician and specialist filed the official complaint in the same week, but not on the day of the incident.Dr.(b)(6) is a pain specialist with a practice in (b)(6).The patient was implanted on (b)(6) 2017 with a fr8a-rcv-a0 and fr8a-rcv-b0 stimulator following successful trial period.There were no complication experienced during the procedure, and the patient was sent home following recovery with adequate coverage and pain relief.On (b)(6) 2017, the patient noted a change in therapy and met with (b)(6) for reprogramming the stimulation parameters of the waa.The reprogramming session was not successful, thus, the patient was referred to dr.(b)(6) for x-rays to determine if the stimulator had migrated.On (b)(6) 2017, x-rays confirmed stimulator migration and fracture of the b stimulator at the marker band, used for identification purposes (one marker band for channel a, two marker bands for channel b), and denotes the end of the device and the start of empty tubing.Stimwave's clinical representative, (b)(6), confirmed that only the b stimulator had migrated and the a stimulator maintained its original placement.While the b stimulator had fractured, it remained in tact above the marker band, thus (b)(6) recommended to attempt reprogramming the stimulator to re-establish therapy, which the patient and dr.(b)(6) agreed.The patient reported no adverse side effects or secondary effects, and that he would reach out again if therapy was not adequate.Following the x-rays, stimwave attempted to discuss details of the procedure with dr.(b)(6) for complaint records, but dr.(b)(6) was uncooperative with stimwave and (b)(6).Thus, stimwave discussed the (b)(6) 2017 procedure with (b)(6) who was present and programmed the stimulator.(b)(6) noted that dr.(b)(6) was utilizing a unique suturing concept he had developed to secure the stimulator.The ifu describes the need to suture the stimulator to tissue below the marker band (so that the marker band is as superficial as possible), but does not detail the type of knot or suture to use.(b)(6) believes that the final position of the b stimulator marker band was placed very deep in the tissue, and not superficially as outlined in the ifu.While not explicitly stated in the ifu, the imagery of the anchoring procedure shows a marker band visible in the incision above the location of the anchor (which should be in the fascia layer).It is worth noting that during clinician training labs hosted by stimwave, clinicians are taught to place the stimulator in such a way that the marker band is fully visible during anchoring and to ensure that this part of the stimulator is not "buried deep" into tissue should an explant be required.Dr.(b)(6) attended a training course in (b)(6) in (b)(6) 2015 in which this method was taught to all attendees.(b)(6) stated that dr.(b)(6) created the subcutaneous pocket and fixated the receiver using the suture sleeve cap provided with the receiver kits.(b)(6) was able to establish comfortable paresthesia for the patient.Following closing the incisions, the patient proceeded to recovery and was discharged same day.This is the first reported case of fracture of the device in vivo for a freedom stimulator.The deviations from standard, prescribed placement and anchoring procedures may have contributed to the complaint.In a previous complaint, compressive forces on the marker band contributed to fracture at the marker band on removal of the trial device.The unique suture knot applied for fixation may have caused excessive forces on the empty tubing portion of the device distal to the marker band causing the eventual fracture of the device in between the two marker bands.The x-rays do not detect the sutures or suture sleeve cap of the stimulator, but the distance between the last electrode and the marker band demonstrates that the stimulator remains in tact, with the a stimulator maintaining its position, which is why reprogramming was scheduled and completed on (b)(6) 2017 as a final attempt to recover therapy, but was unsuccessful.The fracture at the marker band does not impact the safety of device.Additional x-rays will monitor any further migration.The components within the stimulator remain sealed to tissue based on the manufacturing process of the stimulator (pellethane is reflowed over all electrical components from tip of the device to the marker band).Explant was scheduled with neurosurgeon per the patient's request for (b)(6) 2017.The root cause of the complaint is attributed to clinician practice and noncompliance to stimwave-issued training and procedure for implanting and anchoring stimulators.This is the second complaint of stimulator fracture, and the first for a permanent implantation.Capa is not required to respond or remedy this complaint.Due to the similarities of compressive forces (sutures and unique knotting technique) leading to fracture, the information from this complaint will be included in the root cause investigation for the capa opened to evaluate design changes to eliminate the potential for fracture based on deformation of the of marker band.On may 25, 2017, stimwave reminded (b)(6) that all instances of issues with stimwave products should be communicated with stimwave quality immediately, so that proper action can be taken.On may 25, 2017, again stimwave attempted to contact dr.(b)(6) to describe the root cause as identified by investigation based on the provided narrative from (b)(6), but he was unable to be reached and calls placed to his office were not returned.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 the patient elected medical or surgical intervention.Stimwave has reported this as an adverse event to the united states food and drug administration (fda) on march 4, 2019.Stimwave acknowledges that this event is reported late, but is being reported as part of corrective and preventive action (not related to this issue) to ensure compliance to adverse event reporting procedures and the regulations.

Event Description

Following the x-rays, stimwave attempted to discuss details of the procedure with dr.(b)(6) for complaint records, but dr.(b)(6) was uncooperative with stimwave and (b)(6).Thus, stimwave discussed the (b)(6) 2017 procedure with (b)(6) who was present and programmed the stimulator.(b)(6) noted that dr.(b)(6) was utilizing a unique suturing concept he had developed to secure the stimulator.The ifu describes the need to suture the stimulator to tissue below the marker band (so that the marker band is as superficial as possible), but does not detail the type of knot or suture to use.(b)(6) believes that the final position of the b stimulator marker band was placed very deep in the tissue, and not superficially as outlined in the ifu.While not explicitly stated in the ifu, the imagery of the anchoring procedure shows a marker band visible in the incision above the location of the anchor (which should be in the fascia layer).It is worth noting that during clinician training labs hosted by stimwave, clinicians are taught to place the stimulator in such a way that the marker band is fully visible during anchoring and to ensure that this part of the stimulator is not "buried deep" into tissue should an explant be required.Dr.(b)(6) attended a training course in (b)(6) in (b)(6) 2015 in which this method was taught to all attendees.(b)(6) stated that dr.(b)(6) created the subcutaneous pocket and fixated the receiver using the suture sleeve cap provided with the receiver kits.(b)(6) was able to establish comfortable paresthesia for the patient.Following closing the incisions, the patient proceeded to recovery and was discharged same day.

• 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: 8388476
• MDR Text Key: 137852526
• Report Number: 3010676138-2019-00012
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162161
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO170123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2017
• Device Age: 5 MO
• Event Location: Ambulatory Surgical Facility
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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