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

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/30/2009

Event Type  Death  

Event Description

Additional information was obtained and it was found that the patient¿s date of death was actually (b)(6) 2009 and the patient passed away at the hospital.The patient was admitted to the hospital on (b)(6) 2009 with acute atrial fibrillation with fast response, hypotension, and probable pneumonia.The history of present illness details that the patient had serial life threatening problems over the last two months which included an intracerebral hemorrhage with resulting hemiparesis and marked cognitive and physical deficits.A feeding tube was placed a week prior to the hospital stay because of dysphagia and recurrent aspiration.The patient had an acute mi, pneumonia, svt, and blood pressure difficulties prior to placement.Tachycardia at a rate of 180 led to him being sent to the er.The svt proved quite difficult to control as he was found to have a large intraventricular clot that they did not anticoagulate because of the intracerebral hemorrhage.The physician wished to move the patient to hospice due to the poor prognosis, but his brother wanted gentle care.In a progress note addendum, the physician convinced the patient¿s family to move the patient to hospice care because ¿his prognosis is essentially zero.¿ the patient had another mi while in the hospital, but the patient's heart rate and blood pressure somewhat stabilized.The patient was eventually discharged on (b)(6) 2009, the date of death.

Manufacturer Narrative

Outcomes attributed to adverse event: death, corrected data: the initial report indicated the date of death was (b)(6) 2009 however, it was (b)(6) 2009.The information has been corrected in this report.Date of event, corrected data: the initial report indicated that the date of the event was (b)(6) 2009 however it was (b)(6) 2009.The information has been corrected in this report.

Event Description

It was reported that the vns patient passed away on (b)(6) 2009.The cause of death is unknown.Review of the available programming and diagnostic history showed normal diagnostic results through 2009.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• Brand Name: PULSE GEN MODEL 102
• 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: 3673246
• MDR Text Key: 19352731
• Report Number: 1644487-2014-00662
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2008
• Device Model Number: 102
• Device Lot Number: 015579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2006
• 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): Death
• Patient Age: 62 YR