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

Model Number STQ4-SPR-B0

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

During the implant procedure, the lumen broke while the implanting clinician was tying a knot and the decision was made to remove the stimulator.The implanting clinician was able to complete the procedure with additional product provided by the clinical representative and did not experience the same issues with the additional device provided.The patient did not report any issues with the device or therapy.The clinical representative confirmed that no visual defects were identified on the lumen before the implant procedure.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, kinked lead and use of incorrect tools were ruled out as potential causes.The no therapy/loss of therapy questionnaire was also reviewed for potential causes of the reported issue.Severe force or bending during implantation, improper surgical technique, and not using care when replacing the stylet are potential causes of a damaged stimulator.The implanting clinician stated excessive force was not applied during the procedure and stated that the cause of the broken lumen was unknown.However, the source of the issue is likely attributed to how the device was handled during the procedure.The stimulator is used to treat pain.The cause of the damaged/fractured stimulator was caused by severe force or bending during implantation and clinician user error.

Event Description

During a permanent implant procedure, dr (b)(6) had a stimulator lumen break while tying the knot.She had to remove the stimulator and place a new one.

• Brand Name: STIMQ NEUROSTIMULATOR
• Type of Device: PERIPHERAL 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: 11868356
• MDR Text Key: 252137634
• Report Number: 3010676138-2021-00097
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: 010081822502049517230101
• 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: 05/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO210125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• 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