MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC FREEDOM NEUROSTIMULATOR; SPINCAL CORD NERVE STIMULATOR

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

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The patient needed to get an mri because the patient was experiencing a new pain experienced unrelated to the stimulator.The mri facility confirmed that the approved parameters on the stimwave website were followed at the mri examination time.The clinical representative followed-up with the patient and was able to determine that the patient was receiving therapy until the date of the mri procedure.The patient followed up with the implanting clinician at an unknown date.The implanting clinician performed x-rays during the follow-up and confirmed migration did not occur.The implanting clinician explanted the stimulator on (b)(6) 2020.The stimulator was reported to meet product specifications.The device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.The cause of the reported event could not be determined with the information available during the investigation.

Event Description

On (b)(6) 2020, the patient called the cr reporting experiencing several unpleasant electric shocks in the left leg during an mri examination, and the examination was stopped immediately.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINCAL CORD NERVE 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11073603
• MDR Text Key: 223703856
• Report Number: 3010676138-2020-00180
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO191212, SWO200206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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