MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM-8A NEUROSTIMULATOR; SPINAL CORD STIMULATOR

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following the notification, stimwave quality and the cr reviewed the events preceding this event.On (b)(6) 2020, one freedom-8a spinal cord stimulator each was implanted at the top of the t8 and t9 vertebrae to treat low back and hip pain.This complaint involves only the stimulator identified in the "device data" section.The cr confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication.The cr stated that on (b)(6) 2020, the patient met with the implanting clinician due to feeling a "pulling" sensation.The physician found that one stimulator had migrated deeper up to the fifth thoracic vertebra and would require revision.Per the physician and the cr, the cause of the migration is unknown.The patient stated that no scratching, falls or overexertion occurred that may have caused the migration.The cr stated that the date of the revision has been postponed due to cessation of non-essential procedures caused by the covid-19 pandemic.Stimulator migration is a known adverse event for spinal cord stimulators and has been evaluated to have been reduced as far as possible in stimwave's risk management file.The device did not fail to perform its essential functions; the patient received therapy until the event occurred.The root cause of this event could not be attributed to the inability of the devices to meet physical, functional, performance and/or safety specifications.The cause of the migration cannot be deduced with the provided evidence but may have been caused by contributing factors such as patient physiology, natural physiological movements, or clinician suturing technique.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications, and no trend of migration is evident for this product lot.Stimwave has confirmed that the issue is a known adverse event, reduced as far as possible, and documented in the stimwave risk management file.Stimwave was in contact with the cr from march 19, 2020, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to reduce migration, and 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 surgical intervention will be performed to prevent or preclude permanent impairment or damage.
Event or Problem Description
Stimwave quality has investigated the details regarding a migration reported to stimwave on march 19, 2020, by clinical representative.

• Brand Name: FREEDOM-8A NEUROSTIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 9925427
• Report Number: 3010676138-2020-00037
• Device Sequence Number: 3296239
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: 010081822502067917211101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO191113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention