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

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

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

Patient Problems Pain (1994); Numbness (2415)

Event Date 07/20/2022

Event Type  Injury  

Event Description

The patient reported spasms, numbness, tingling, and pain.The device was reprogrammed and replacement antennas were provided to the patient.The clinical representative has reached out to the patient for additional reprogramming.However, they have not been able to make contact with the patient.There are no plans for an explant or revision at this time.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.However, the questionnaire was completed by quality with limited information.Migration was ruled out as a potential cause of the reported issue.Other potential causes of the reported issue are improper programming parameters, patient contraindications and off-label use.The spasms were present before the implant procedure.The patient was prescribed baclofen which they took during the trial.However, the patient has not consistently taken the medication since the permanent implant procedure.After reprogramming the device, the pain remained the same except in the patient's legs and feet seemed to be better.The clinical representative contacted the patient on august 9, 2022, to offer to reprogram again.The contact was unsuccessful.The stimulator is used to treat pain.The cause of the reported issue is unknown.Past reprogramming increased pain relief, which indicates the system is functioning; however, the patient did not respond to the stimwave representative to meet for an additional reprogramming session.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 unintended stimulation/new pain.Unintended stimulation/new pain rates remain acceptably low; thus, capa is not required.Unintended stimulation/new pain rates will continue to be tracked and trended.

• 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: 15246785
• MDR Text Key: 298113801
• Report Number: 3010676138-2022-00103
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)240101(01)00818225020693(17)230801(21)2B13203-45
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Model Number: FR8A-SPR-B0, FR8A-RCV-A0
• Device Lot Number: SWO220118, SWO210811
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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