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

Model Number FR8A-RCV-A0; FR8A-RCV-A0

Device Problem Expulsion (2933)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 10/13/2019

Event Type  Injury  

Manufacturer Narrative

Stimwave quality has investigated the details regarding a complaint resulting from a device erosion reported to stimwave on october 14, 2019, by territory manager.Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which two (2) freedom receiver stimulator (fr8a-rcv-a0) were implanted at the t8-t9 vertebral level.The territory manager confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the territory manager maintained contact with the patient following implant.On (b)(6) 2019 the patient visited the hospital due to pain at the incision site.The patient was treated in the emergency room (er), and when the patient bent over, the receiver stimulator was expulsed out the skin.The device was removed at the er.The territory manager was contacted by the patient on (b)(6) and reported the event.The territory manager reported the patient is a slow healer and the implant wound had not healed at the moment of the reported event.The patient was still getting therapy from their second device at the time of the event.On (b)(6) 2019, the patient visited the implanting clinician for follow up.The implanting clinician evaluated the wound and noticed the patient had drainage at the pocket site of the remaining device.The implanting clinician believed the implant site was infected and made the decision to explant the device prophylactically.The patient was placed on antibiotics (duration and dosage unknown).The patient reported to be receiving therapy up from their device until the moment of explant.The root cause of the issue cannot be traced to the device.The root cause of the issue is likely caused by the patient's slow healing.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for either lot, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Infection is known adverse event for spinal cord nerve stimulators that is mitigated as far as possible in the product's risk management file.The source of the issue cannot be traced back to the device or procedure.The device did not fail to meet performance or safety specifications.Stimwave will continue to track and trend events.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 to patient's wound not healing.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 territory manager from october 14, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the product did not fail to meet performance and safety specifications.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 this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on november 7, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from a device erosion and infection reported to stimwave on october 14, 2019, by territory manager.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR SYSTEM
• Type of Device: SPINAL CORD STIMULATION
• 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: 9293457
• MDR Text Key: 173450886
• Report Number: 3010676138-2019-00042
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210601(01)00818225020693(17)210601(21)210069-80
• 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: 11/07/2019

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: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Model Number: FR8A-RCV-A0; FR8A-RCV-A0
• Device Lot Number: SWO190621; SWO190621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2019
• 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): Hospitalization; Required Intervention