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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bradycardia (1751)

Event Date 07/04/2015

Event Type  Injury  

Event Description

It was reported on (b)(6) 2015 that a patient had cardioversion performed and then starting having severe coughing every 90 seconds during stimulation.The nurse believed that the coughing was related to vns stimulation.The patient's magnet was placed over the generator to inhibit stimulation.The patient was then transported to another hospital, where he experienced bradycardia associated with stimulation.The patient's generator was disabled, which resolved the bradycardia.Attempts for further information have been made but no relevant information has been received to date.

Event Description

Monophasic cardioversion was performed at 100j with patches, one on the left-medial chest and one on the upper-middle of the back.According to the physician who performed the cardioversion, the patient was coughing during the procedure.After the cardioversion, the patient kept coughing and had repeated, regular asystole periods that were 14 seconds long.The physician who performed the cardioversion believed that vns stimulation led to ventricular tachycardia and asystole.Attempts for further information have been made, but no relevant information has been received to date.

• 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: 4950732
• MDR Text Key: 6034249
• Report Number: 1644487-2015-05360
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2011
• Device Model Number: 102
• Device Lot Number: 201053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 23 YR