MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR

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

Device Problem Expulsion (2933)

Patient Problem Skin Erosion (2075)

Event Date 11/02/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the clinical specialist reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) receiver stimulator (fr8a-rcv-a0) and one (1) spare lead (fr8a-spr-b0) were implanted bilaterally at the t8-t9 vertebrae for chronic lower back pain.Prior to the procedure, the clinical specialist attending the procedure advised the implanting clinician to use the injectable anchor system.However, the implanting clinician did not use the anchor system when implanting the device.The procedure was completed without complications, and the clinical specialist maintained contact with the patient following the implant.On (b)(6) 2019, the patient contacted the clinical specialist to report the patient had been admitted to the emergency room (er) due to a device erosion through the skin.The patient reported they felt the device protrude when they sat down.The patient was treated by a doctor while at the er.The doctor evaluated the wound and contacted the implanting clinician.The device had moved backwards, and a portion of the device had eroded at the needle entry site.The implanting clinician and the doctor made the decision to insert the portion of the device that had eroded back into the implant site.The doctor sutured the wound once again and closed the wound.There were no other complications reported.The device eroded through the unhealed wound due to improper anchoring of the device.The use of the anchor system prevents the device from moving from the implanted position.On (b)(6) 2019, the patient visited the implanting clinician and the clinical specialist for follow up.The patient reported the device was working as expected and they were receiving therapy from their device.The implanting clinician evaluated the implant site and reported it was healing appropriately.Device erosion is a known adverse event for spinal cord stimulation and the freedom scs system and is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause is attributed is attributed to 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 risk management file.Stimwave was in constant contact with the clinical specialist from (b)(6) 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to mitigate device erosion, and that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to the implanting clinician not using the injectable anchor system.Stimwave has informed all parties that the product was not the source 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 erosion of the device through the skin 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 november 22, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from device erosion reported to stimwave on november 2, 2019, by clinical specialist.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• 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: 9365697
• MDR Text Key: 168203513
• Report Number: 3010676138-2019-00056
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)211001(01)00818225020648(17)210901(21)210862-75
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182720
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO191002, SWO190925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2018
• 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