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

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

It was reported that the patient attempted to disable the vns device by taping the magnet over the generator however the device did not disable.The patient's magnet placement has not been observed by the physician to ensure that it is sufficient to disable the generator.The most recent lead impedance was reportedly normal.No additional relevant information has been received to date.

Event Description

It was reported that the generator had been programmed off by the physician after the patient was unable to disable the device with the magnet.The reason for the device being programmed off was due to the patient experiencing chest pain, painful stimulation and an increase in seizures.No additional relevant information has been received to date.

Event Description

It was later reported that the patient passed away from a drug overdose.During follow-up with the physician it was reported that the patient had a long history of being non-compliant and was suffering from other issues that were not related to vns.The physician suspected that the reported symptoms and issues with her vns were likely more related to the patient's "extracurricular activities" rather than vns therapy.

• 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: 5945770
• MDR Text Key: 54927364
• Report Number: 1644487-2016-02032
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 103
• Device Lot Number: 202049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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: 30 YR