MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101; GENERATOR

Model Number 101

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

Patient Problem Death (1802)

Event Date 07/12/2014

Event Type  Death  

Event Description

An obituary for the patient was found and indicated that the patient had passed away unexpectedly in 2014.The cause of death has not been obtained to date.No autopsy was performed.The funeral home who saw the patient after he passed indicated that no devices were removed from the patient prior to burial.The most recent diagnostics as of (b)(6) 2010 indicate that the patient's generator was functioning properly.A battery life calculation was performed with the available information and indicated that the patient's generator had approximately 1.7 years remaining from (b)(6) 2009.Based on the battery life remaining, it is suspected that the generator may have reach end of service prior to the patient's death.An internal sudep evaluation was performed by the manufacturer which determined the death to be probable sudep.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 101
• 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: 6440670
• MDR Text Key: 71092456
• Report Number: 1644487-2017-03397
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2003
• Device Model Number: 101
• Device Lot Number: 5757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2002
• 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: 61 YR