MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scarring (2061); Neck Pain (2433)

Event Date 06/09/2020

Event Type  Injury  

Event Description

It was reported that the patient is complaining of pain over the incision site.The discomfort occurs when the patient turns her neck or when the neck is in a certain position.The physician initially reported the pain is not related to the vns however x-rays were taken and reviewed.Diagnostics were reported to be within normal limits and no dosing changes were made that would contribute to the pain.There were no reported falls or anything out of the ordinary that would have caused pain per the patient.X-rays were reviewed.The connector pin can be seen coming through the second connector block.The filter feedthrough wires were confirmed to be intact.The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest.A strain relief loop and bend were present.The lead wire bodies are aligned parallel to each other after the strain relief loop.Two tie downs were used; one appeared to be present on the lead before the strain relief loop in the neck and one was used on the bend.The lead wires appeared intact at the connector pins.No gross fractures or discontinuities and no sharp angles were observed in the lead portion that could be visualized.The patient was then referred for generator replacement due to the battery being at 25%.The notes from the physician state on interrogation and imaging there are no lead impingements.Further information was received that the surgery is also exploratory for the keloids and pain reported.Information was received that the patient's device was explanted and replaced due to prophylactic reason per the implant form.The device was reportedly discarded and therefore not received into analysis to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10871286
• MDR Text Key: 217464926
• Report Number: 1644487-2020-01557
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2020

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: 09/23/2017
• Device Model Number: 106
• Device Lot Number: 4568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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 Age: 31 YR