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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Atrial Fibrillation (1729); Dyspnea (1816); Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 01/25/2014

Event Type  Injury  

Event Description

It was reported that the vns patient who is enrolled in the (b)(6) clinical study presented with syncope which required hospitalization.The treating physician believes the syncope event is probably related to stimulation of the vns device.The patient was implanted with the device in (b)(6) 2012, and the syncope events began on (b)(6) 2014.During hospitalization, the patient regained consciousness in about five minutes without any episode, but had sudden onset of loss of consciousness on the same day, while still in the hospital.The patient regained consciousness and an ecg showed intermittent atrial fibrillation.The ecg also revealed sustained monomorphic ventricular tachycardia.The physician does not believe that the tachycardia event is related to vns stimulation.An electrophysiologist advised for aicd (automatic implantable cardioverter defibrillator) implantation which was done on (b)(6) 2014.The patient was hemodynamically stable during and after the procedure.The patient was discharged in a stable condition on (b)(6) 2014.To note, this patient is enrolled in the (b)(6) clinical study sponsored by the manufacturer and the patient has a known medical history of hypertension & coronary artery disease and moderate left ventricular dysfunction (35%).In addition the patient presents with history of shortness of breath functional classification iii as of the prior 2 ¿ 3 months.

Manufacturer Narrative

Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.

Event Description

Information was received that clarified the events.The patient was admitted to hospital with history of loss of consciousness.On further observation and investigation, it was diagnosed as ventricular tachycardia which was not believed to be related to vns therapy.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3647069
• MDR Text Key: 4183481
• Report Number: 1644487-2014-00521
• 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: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2014
• Device Model Number: 103
• Device Lot Number: 3348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2012
• 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): Hospitalization; Life Threatening
• Patient Age: 54 YR