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

Model Number FR8A-TRL-A0, FR8A-TRL-B0

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

Patient Problems Device Overstimulation of Tissue (1991); Perforation (2001)

Event Date 11/07/2022

Event Type  Injury  

Event Description

The clinical representative reported a trial procedure was aborted as the implanting clinician punctured into intrathecal space during first attempt with excess blood return.The clinician attempted to implant a level above.However, the patient felt overstimulated with testing and the clinician aborted the case.The patient was sent for mri immediately after the procedure was aborted.The patient is currently doing well and no further issues have been reported.

Manufacturer Narrative

The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident occurring before the implant of the device and implanting the device in an off-label location, have been ruled out as potential causes.However, the questionnaire shows medical intervention was required to prevent serious injury and tissue was punctured during the procedure.The stimulator is used to treat pain.The cause of the reported issue is incorrect surgical technique as the implanting clinician punctured into intrathecal space (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required.Other adverse events issues rates will continue to be tracked and trended.

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 15898851
• MDR Text Key: 304682742
• Report Number: 3010676138-2022-00143
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020679
• UDI-Public: (01)00818225020679(17)240101(01)00818225020662(17)240401(21)2B14811-26
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2022

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: 01/01/2024
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO220118, SWO220428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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