MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Degraded (1153)

Patient Problem Chest Pain (1776)

Event Date 05/27/2015

Event Type  Injury  

Event Description

It was reported that the patient was experiencing daily chest pain and thus wanted the vns explanted the treating neurologist wanted to begin the process of referring the patient for explant.Additional information was received that the pain has been occurring daily since (b)(6) 2015.The vns was disabled on (b)(6) 2015.The cause for the pain was believed to be the presence of the device.No known interventions were planned or scheduled at the time, other than the device disablement.Additional information was received that the patient was being scheduled for vns explant surgery due to the daily chest pains and associated shortness of breath.The patient's vns settings and diagnostics were reported to be as intended and within normal limits.

Event Description

Additional information was received that the patient was scheduled for vns explant surgery.The surgery has not occurred to date.No additional pertinent information has been received to date.

Event Description

It was reported that the patient's generator explant surgery was completed.The explanted generator was returned to the manufacturer and is currently undergoing product analysis.No additional pertinent information has been received to date.

Event Description

Product analysis was completed for the returned generator.There were no performance or any other type of adverse conditions found.Besides explant related observations, visual examination did not observe surface anomalies on the generator.The septum was not cored, eliminating that as a possible path for current.No anomalies were detected from the internal device data.Both interrogation and system diagnostic tests were performed and were within normal limits.The generator showed no signs of variation in the output signal in 24-hour simulated monitoring and demonstrated the expected level of output current.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 5353601
• MDR Text Key: 35355520
• Report Number: 1644487-2016-00058
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2015

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: 10/22/2014
• Device Model Number: 103
• Device Lot Number: 202298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/12/2016; 03/28/2016; 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 19 YR