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

Model Number 103

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

Patient Problems Cardiac Arrest (1762); Death (1802); Vomiting (2144); Loss of consciousness (2418); Vascular System (Circulation), Impaired (2572)

Event Date 09/10/2015

Event Type  Death  

Event Description

It was reported that the patient died due to cardiac/circulatory arrest on (b)(6) 2015.Additional information was received from the neurologist that the patient was receiving vns therapy treatment at the time of death.Patient response to vns therapy was seizure reduction.The neurologist did not know the cause of death but indicated that the patient was found unresponsive in asystole (in bed) at 6:30 am with dried vomit.The believed relationship between the vns system and cause of death was reported to be "probably not related".Patient had epilepsy since childhood and experienced 2nd generalized (5-6 per day) and infantile spasms.Patient did not undergo respective epilepsy surgery.Patient does not have a history of drug or alcohol abuse or cardiac or respiratory problems.Patient was taking antiepileptic drugs and was compliant.Patient's death certificate could not be obtained as it is only available to those who have a personal or property right interest with the decedent.It was reported by the funeral home that the patient was cremated and that they do not have any of patient's devices.An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

• Brand Name: PULSE GEN MODEL 103
• 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: 5174551
• MDR Text Key: 29166853
• Report Number: 1644487-2015-06218
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 103
• Device Lot Number: 202198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2012
• 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): Death
• Patient Age: 42 YR