MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Dementia (1808); Myocardial Infarction (1969); Depression (2361)

Event Date 12/01/2015

Event Type  Death  

Manufacturer Narrative

Suspect device udi: (b)(4).

Event Description

It was reported that the patient passed away on (b)(6) 2015.The nurse reported that the patient has a history of dementia and depression.The coroner reported that the patient drowned in the river by his home.The coroner's office indicated he may have fallen by his home as evidenced by blood found on the porch of his home and he was not seen alive thereafter, but no foul play was suspected.The preliminary autopsy findings indicate the patient suffered from two prior heart attacks with 50% blockages in several coronary arteries but no thrombi.The autopsy authorization form was received which reported that the patient vns therapy has reduced the length of the patient's seizures, and he had not had a known seizure since (b)(6).The patient was found in the river over a mile from his home.He was caught on a pier, and he had been reported missing the previous evening.He lives in an apartment in from of his brother's home.He usually brings the mail at a particular time of day.When he didn't, his brother went to look for him, eventually calling police.The found the mail strewn on the front steps of the home with a small blood spot on the first step.The patient was found in the river by police.The cause of death is unclear.The explanted products were received by the manufacturer for analysis.However, analysis has not been completed to death.

Event Description

Analysis was completed on the explanted devices.The pulse generator performed according to functional specifications throughout all testing in the analysis lab.The battery showed an ifi=no condition.There were no performance or any other type of adverse condition found with the pulse generator.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.No other anomalies were identified in the returned lead portion.

Event Description

The coroner reported that it is assumed that the patient became confused post-ictally and walked in the opposite direction of his brother's home in the direction of the lake.They assume that he then inadvertently walked into the water and was taken by the water.

• Brand Name: PULSE GEN MODEL 106
• 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: 5312869
• MDR Text Key: 33933707
• Report Number: 1644487-2015-06803
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2017
• Device Model Number: 106
• Device Lot Number: 203485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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: 69 YR