MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Arrhythmia (1721)

Event Date 01/01/2017

Event Type  Injury  

Event Description

It was that the patient was experiencing palpitations, intermittent coughing, dysphagia and perceiving erratic stimulation from her vns generator.The patient was evaluated by the physician who lowered the vns magnet mode output current.Diagnostic testing was performed and resulted within normal limits.X-rays and an ecg were performed however no lead issues were observed by the physician and radiologist.The x-ray images have not been reviewed by the manufacturer to date.Over the following weeks, the patient developed a cough and shortness of breath.Then the following month, the patient presented to the emergency room with sepsis that had developed from community acquired pneumonia.The patient was admitted to the hospital and it was noted that the patient was experiencing tachycardia.The physician was unsure what caused the reported symptoms but noted that it could have been related to the patient developing pneumonia.Additionally, the physician suspected that the tachycardia may have contributed to the patient perceiving erratic vns stimulation.If the patient continued to be symptomatic, the physician was going to consider reducing the programmed output.No additional relevant information has been received to date.

Event Description

The physician reported that the vns output current was reduced following the tachycardia event.The tachycardia then resolved on its own.

Event Description

The patient underwent vns generator replacement surgery due to battery depletion.Attempts at product return revealed that the facility, historically, does not return explanted products.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6446802
• MDR Text Key: 71284873
• Report Number: 1644487-2017-03518
• Device Sequence Number: 1
• Product Code: LYJ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 102
• Device Lot Number: 201883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2011
• 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: 33 YR