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

Model Number 102

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Bradycardia (1751); Headache (1880); Nausea (1970); Loss of consciousness (2418); Chest Tightness/Pressure (2463)

Event Date 11/25/2015

Event Type  Injury  

Event Description

It was reported through an article that a patient with a vns for refractory depression presented with bradycardia and orthostasis 9 years after initial implant of the vns.This was reported by the patient as recurrent syncopal episodes occurring for duration of 1 month.The patient reported 3 - 5 syncopal episodes occurring every other day, with loss of consciousness lasting 5 - 7 minutes.These episodes were preceded by lightheadedness, shortness of breath, nausea, and chest pressure radiating to her left arm and the patient also denied any triggers.The patient also denied loss of consciousness, which contradicts the initial report.The patient's past medical history was notable for anxiety and bipolar disorder associated with severe refractory depression.Over her lifetime, she had been treated with multiple lines of medication and over 70 documented electroconvulsive therapy treatments.Upon the patient's admission, her vital signs were within normal limits, cardiac examination was unremarkable, cardiac evaluation including measurement of cardiac enzymes and 2-dimensional echo were all within normal limits.Serial ekgs were significant only for occasional sinus bradycardia in the low 50s.Urine drug screening was negative and the ct was normal.Records from an outside hospitalization a month prior for these same symptoms demonstrated a normal ct angiogram of the head and neck, normal continuous eeg monitor, and continuous telemetry without arrhythmias.During the first half of admission, the patient's blood pressures fluctuated significantly.These findings were note despite having been adequately hydrated with crystalloid solution prior to the assessments.Additionally, a complete neurologic exam and workup had been unremarkable and her medications were reviewed and deemed non-contributory.As a result, a decision was made to inactivate the vns.Variation in systolic and diastolic blood pressures diminished in a statistically significant manner after the vns was inactivated.The patient also endorsed improvement of her symptoms.The patient was then deemed stable and discharged.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 5446594
• MDR Text Key: 38558839
• Report Number: 1644487-2016-00350
• Device Sequence Number: 1
• Product Code: MUZ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2016

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 Model Number: 102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR