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

Model Number FR8A-SPR-B0

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the product being damaged before the procedure has been ruled out as potential cause of the reported issue.However, the clinician inadvertently cut the lead due to incorrect technique.Thus, the cause of the damaged/fractured stimulator is due to incorrect surgical technique (user error - clinician).The stimulator is used to treat pain.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.

Event Description

During the permanent implant procedure, the implanting clinician inadvertently severed the lead and broken/fractured pieces of the stimulator were left implanted.The physician seemed to have made an education decision based on their knowledge of the area/patient to leave the fractured portion of the lead behind.Fluoro images were taken to determine the next steps and a follow-up appointment is scheduled for (b)(6) 2022.

• 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: 15077961
• MDR Text Key: 296339043
• Report Number: 3010676138-2022-00093
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)230301
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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