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

Model Number 101

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

Patient Problems Death (1802); Seizures (2063)

Event Date 08/15/2009

Event Type  Death  

Event Description

It was initially reported that a patient passed away.The cause of death was believed to be seizure related and unrelated to the patient¿s vns device.Follow-up with the county where the patient passed away revealed that the patient was found dead on his bedroom floor by his caregiver.An hour prior to the death, the caregiver checked in on the patient and thought he was lying awake in the bed and was making an unusual ¿snoring¿ sound.Thirty minutes later, the caregiver checked in on the patient again, and the patient appeared to be sleeping in the bed.Thirty minutes after that, the caregiver found the patient lying supine on the bedroom floor.There was no evidence of trauma or that the patient choked on anything.The patient was pronounced dead thirteen minutes later.The patient was taking multiple medications prior to his death which included: oxcarbazepine, banzel, topamax, dilantin, folic acid, clonazepam, glycolax, pericolace, and fibercon.An autopsy was performed and the cause of death was listed as cerebral palsy with refractory seizures (epilepsy).The manner of death was listed as natural.An internal sudep evaluation was performed and the death was determined to be a definite sudep.

Manufacturer Narrative

The physician stated the death was unrelated to vns however, as the death is a definite sudep, the exact cause of death and the relationship to vns remains unclear.

• Brand Name: PULSE GEN MODEL 101
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS INC; 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: 4436716
• MDR Text Key: 21550936
• Report Number: 1644487-2015-03670
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2003
• Device Model Number: 101
• Device Lot Number: 5757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/20/2015
• 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: 37 YR
• Patient Weight: 65