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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Death (1802); Weakness (2145); Loss of consciousness (2418)

Event Date 01/08/2013

Event Type  Death  

Event Description

Analysis of the returned generator and lead was completed.An end-of-service (eos) condition was found with pulse generator.There were no performance or any other type of adverse conditions found with the pulse generator.There is no evidence to suggest an anomaly with the returned lead portion.Note that since a large portion of the lead assembly was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Event Description

An explanted generator and lead were received for analysis from another medical device manufacturer.The devices had been inadvertently returned to the wrong manufacturer.It was noted that the vns patient had passed away.It was noted that in the last several weeks the patient had been feeling weak and his breathing had stopped.The patient was unresponsive on arrival.No cause of death or relationship of the death to vns was indicated.It was noted that an autopsy was performed.No additional relevant information has been received to date.Analysis of the devices are underway, but have not been completed to date.

Manufacturer Narrative

Cyberonics, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

Event Description

This death information has been reviewed by the medical device manufacturer and with the available information has been determined to be possible sudep.It is not known what state of health the patient was in, or the manner of death, or the cause of death.The physician's office was unable to provide any information as they had no records on the patient.

• 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: 4167523
• MDR Text Key: 4990157
• Report Number: 1644487-2014-02673
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 103
• Device Lot Number: 201224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2009
• 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: 60 YR