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

Model Number 103

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

Patient Problem Death (1802)

Event Date 12/18/2016

Event Type  Death  

Event Description

It was reported that the patient had passed away, as confirmed through an online obituary.She was found unresponsive by the nursing staff at her care facility after a possible seizure.Cpr was attempted, but the patient had expired.The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days.The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution.Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.No additional pertinent information has been received to date.

Event Description

The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it.Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy.The office confirmed that no warnings for abnormal impedance were seen in the last office visit.The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity.The patient then had a seizure and was also found to be very hypoxic.Computed tomography angiography (cta) showed many pulmonary embolisms.The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased.Once patient was medically stable, she was transferred to the rehabilitation center.The next day, the patient had a witnessed seizure and appeared to be stable following the seizure.Approximately one hour later, the patient was found pulseless in her room.She was rushed to the hospital and had cpr performed without success.The patient was pronounced dead by the hospital emergency department.No additional pertinent information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 6252764
• MDR Text Key: 64881708
• Report Number: 1644487-2017-03032
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 103
• Device Lot Number: 3765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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