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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Electric Shock (2554)

Event Date 12/24/2014

Event Type  malfunction  

Event Description

It was reported that the vns patient experienced a shocking sensation in his chest that lasted approximately five minutes after walking through a metal detector.The shocking sensation occurred later once more but otherwise the patient was not having any pain.It did not occur during normal stimulation on-times.Follow-up revealed that the patient was unable to tolerate stimulation on-times from his device even at low device settings and was experiencing pain in his chest.No further information relevant to the event has been received to date.

Event Description

Analysis of the returned generator was completed.There were no performance or any other type of adverse conditions found with the pulse generator.The septum was cored but no bodily fluid remnants were observed in the header septum cavity.Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative

Manufacturer Narrative

Adverse event and/or product problem; corrected data.Supplemental mdr #01 inadvertently did not update this field with the additional information that was received.This report is being submitted to correct this data.Outcomes attributed to adverse event; corrected data.Supplemental mdr #01 inadvertently did not update this field with the additional information that was received.This report is being submitted to correct this data.

Event Description

Additional information was received stating that the vns patient was referred for surgery.The patient underwent generator replacement surgery on (b)(6) 2015.Preoperative and postoperative diagnostic results showed normal device function.The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description

Follow-up with the physician¿s office revealed that the patient was seen in (b)(6) 2015 following generator replacement surgery.The patient was doing well and no issues were noted.

Event Description

The patient reported on (b)(6) 2016 that he believed that the generator was turned on (magnet mode only) because the generator was activated by the detectors at the doors of a large retail store, which caused the patient to have painful stimulation from his left neck to his ear, which made him drop to the floor.His stitches also came out because of the fall to the floor.The patient and his mother believed that the device was defective due to the electro-magnetic interference with the device.The patient had the generator explanted due to the painful stimulation, and the patient reported that the generator was analyzed by a vns technician that was certified by the state and had documentation that the device was defective.The patient did not know where the analysis was done.However, the device was returned to the manufacturer and analysis was performed.There were no anomalies identified with the generator other than the septum being cored.There was no bodily fluids inside the septum, though, so there would not have been a path for stimulation to reach the patient body.The patient also reported feeling the painful stimulation in the neck and ear, which is not near the patient generator.Therefore, the painful stimulation can reasonably assumed to not be related to the cored septum.The device performed according to specifications.No further relevant 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: 4430571
• MDR Text Key: 5280921
• Report Number: 1644487-2015-03658
• 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: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 103
• Device Lot Number: 202938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2014
• 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: 27 YR