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

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

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

Patient Problem Electric Shock (2554)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, not following ifu when the mri was performed, using the incorrect type of mri, the patient experiencing a recent fall or injury, the patient having another non stimwave device implanted, and migration have been ruled out as potential causes of the reported issue.The mri facility reported following the ifu when the mri was performed.The stimulator is used to treat pain.The cause of the reported issue is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in issues after an mri.Issues after an mri rates remain acceptably low; thus, capa is not required. issues after an mri rates will continue to be tracked and trended.This complaint was submitted on (b)(6) 2022 and the stimwave aware date was (b)(6) 2022.Due to the delay in reporting and late mdr submission, (b)(4) was opened.

Event Description

On (b)(6) 2021 the patient underwent an mri which scanned the spine.During the mri procedure, the patient felt vibrations in the abdomen which were described as a sensation and uncomfortable.The mri procedure was aborted.Stimwave was made aware of the incident on (b)(6) 2022.However, stimwave quality was notified of the incident on (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: 15341147
• MDR Text Key: 299151552
• Report Number: 3010676138-2022-00106
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004073
• UDI-Public: (01)00859619004073(17)191001(01)00859619004783(17)190701(21)206369-14
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO171023, SWO170630
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• 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