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

Model Number STQ-RCV-A0

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

The procedure was not performed in accordance with the product instructions for use, as the stimulator was placed off-label at the craniofacial supra orbital nerve above the eyebrow.At a follow-up appointment, the implanting clinician prescribed antibiotics and scheduled an explant.The stimwave clinical representative (cr) did not attend the explant procedure as the patient was implanted out of state with a different cr.During the explant, the stimulator fractured.All fractured pieces of the stimulator were successfully removed without complication.There is no evidence that product did not meet specification, and the stimulator was used for treatment of pain.The reported complaint was confirmed.The stimulator was sterilized per specification, and sterile barriers were confirmed to be intact prior to implant.As the infection occurred more than one year after implant, product sterility is not the likely cause of the infection.The cause of the erosion and subsequent erosion/fracture is off-label use (user error).The craniofacial region has limited tissue to implant the stimulator at an adequate depth, which increases the likelihood of erosion if not placed and sutured appropriately.

Event Description

On (b)(6) 2020, the implanting clinician observed the proximal tip of the stimulator above the ear had eroded.Discharge was also observed at the site of erosion.

• 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
• MDR Report Key: 11073602
• MDR Text Key: 223703851
• Report Number: 3010676138-2020-00173
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: 010081822502046417210401
• 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: 11/26/2020

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: 04/01/2021
• Device Model Number: STQ-RCV-A0
• Device Lot Number: SWO190424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 102