MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Hypoxia (1918); Extubate (2402)

Event Date 12/20/2014

Event Type  Injury  

Event Description

It was reported that a patient was implanted with vns for heart failure on (b)(6) 2014.The patient had a history of hypertension and non-critical coronary artery disease.The patient was extubated in the operation room, and then she was transferred to the post-operative ward.While there, she developed sudden bradycardia and hypoxia.The patient was intubated again and was treated with atropine and kept on a ventilator for 3 minutes.The patient was subsequently extubated and kept on an oxygen mask.Mannitol was administered, and vitals were monitored.The patient was transferred to the cardiac intensive care unit and was discharged on (b)(6) 2014.The physician attributed the hypoxia and bradycardia to premature extubation following the vns implantation surgery.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5546490
• MDR Text Key: 41819036
• Report Number: 1644487-2016-00706
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2016

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: 11/30/2015
• Device Model Number: 103
• Device Lot Number: 3832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 55