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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Seizures (2063); Loss of consciousness (2418)

Event Date 05/06/2014

Event Type  Death  

Event Description

Additional information was received stating that the vns patient passed away from pulmonary hemorrhage probably from pulmonary embolism.The patient¿s parent stated that the patient did not look ok following implant surgery; however, the patient was cleared by the surgeon and anesthesiologist.The patient¿s device was never programmed on.An internal evaluation of the available information determined that the death was unlikely sudep.

Event Description

It was reported that the patient passed away the day following initial vns implant.The patient's mother reported that an autopsy was planned and that she did not know if the death was a complication of surgery, stroke, embolism, heart attack, etc.The surgeon indicated that he was "not able" to provide system diagnostics from the implant procedure to confirm device function at the time of implant.The patient was not receiving vns therapy at the time of death.Neither generator or lead were explanted after the patient's death.The believed cause of death was reported to be sudep.The surgeon indicated that the relationship between the vns and death was unknown.The surgeon indicated that an autopsy was not performed and that the patient was found unresponsive by the family.The patient had no history of drug or alcohol abuse and no history of cardiac or respiratory problems.The patient was compliant with antiepileptic medications.

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records of the generator and lead confirmed all quality tests were passed prior to distribution.

• 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: 3853786
• MDR Text Key: 4538625
• Report Number: 1644487-2014-01423
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 102
• Device Lot Number: 202803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• 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: 27 YR