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

Model Number STQ4-SPR-B0

Device Problem Material Erosion (1214)

Patient Problem Skin Erosion (2075)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting a damaged/expired stimulator, not prepping the surface of the skin with an antiseptic solution, not irrigating the site before closure, multiple tunneling attempts and using inappropriate tools have been ruled out as potential causes.The patient did not engage in strenuous activities following the implant procedure.There is no current infection.However, the patient had previously been treated for infection.The root cause has been attributed to no fault found/no problem found.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the erosion is unknown/no problem found.

Event Description

The patient reported erosion of the implanted device through the skin.An explant procedure was performed on (b)(6) 2021 and new leads were placed at different target nerves to continue attempts to treat the patients knee pain.No further issues have been reported.

• 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 12611787
• MDR Text Key: 275874218
• Report Number: 3010676138-2021-00210
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: 010081822502049517230301
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO210301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• 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