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

Model Number FR8A-SPR-B0, STQ4-RCV-A0

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired simulator was ruled out as a potential cause.Other potential causes of the reported issue are off-label use, migration, infection, patient contraindications, implanting a non-sterile device, using inappropriate tools, erosion and surgical issue.The stimulator is used to treat pain.The cause of the new pain 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 new pain.New pain rates remain consistent and acceptably low; thus, capa is not required.New pain rates will continue to be tracked and trended.

Event Description

The patient reported pain at the receiver pocket when they press on it and they can see the wire under the skin.The patient has not been wearing the wearable antenna assembly.Additionally, they have not been able to get an x-ray to confirm stimulator location as they are dealing with other unrelated health issues.

• 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: 14986611
• MDR Text Key: 295704421
• Report Number: 3010676138-2022-00088
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)210701(01)00818225020464(17)211001(21)211054-115
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: FR8A-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO190701, SWO191024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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