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

Model Number FR8A-RCV-A0

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient experiencing a fall or being injured, or performing strenuous activities since implant, the patient having any other implanted pins/screws/devices, and the device migrating have been ruled out as potential causes of the reported issue.The stimulator is used to treat pain.The cause of paresthesia and loss of therapy are unknown.The device may have been implanted in a pns location (paresthesia felt in leg), which is an mri unsafe location for fr8a stimulators, but this could not be confirmed.Therefore, conclusion has been selected as no problem/fault found.

Event Description

On (b)(6) 2019 the patient was implanted with a spinal cord nerve stimulator (serial number: (b)(4)) to treat chronic pain.On (b)(6) 2022 the patient underwent an mri which scanned the same area as the stimulator.30 minutes into the mri, the patient felt strong paresthesia along the left leg.The mri was aborted.Since the mri, the patient has experienced loss of therapy.Stimwave quality attempted to contact the clinical representative on multiple occasions to obtain mri conditions and additional information.However, no response was received.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 14287697
• MDR Text Key: 290771501
• Report Number: 3010676138-2022-00058
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004073
• UDI-Public: 010085961900407317210201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO190225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2022
• 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): Required Intervention