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

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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Cr explained to the patient that activities requiring excessive twisting or stretching should be avoided as it can put undue stress of the stimulators, per the ifu.Based on this information, the new pain and swelling was confirmed/replicated, there is no evidence that product did not meet specification and the stimulator is used for treatment of pain.Since the issue was not attributed to the product, the dhr was not reviewed during the investigation.The potential cause of the new pain and swelling is user error.

Event Description

The clinical representative (cr) reported that the product was implanted in accordance with instructions for use (ifu).(b)(6) 2020, patient reported experiencing new pain and swelling and the implant site after digging a ditch.The patient later reported that new pain and swelling decreased over the following days.

• Brand Name: STIMQ 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11127029
• MDR Text Key: 225499642
• Report Number: 3010676138-2020-00178
• Device Sequence Number: 1
• Product Code: GZB
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO200329, SWO200604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 77