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

Device Problem Unintended Electrical Shock (4018)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

At the time of the call it was not reported that the patient also has pedicle screws (hardware) and is fused at multiple levels of the spine.His scan was done at a 1.5 tesla and in all appearances appropriate procedures were followed for a scan of the fr8a.The patient is going to receive another mri today (b)(6) 2020.Tm spoke to the patient and asked the patient to make sure the mri facility was aware of his fuses and to make sure the facility knows he has these implants as well.

Event Description

An issue was reported with unintended stimulation (a tingle down his leg) during an mri procedure (b)(6) 2019.

• 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,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10077525
• MDR Text Key: 195475809
• Report Number: 3010676138-2020-00057
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• 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: 08/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other