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 Problem Death (1802)

Event Date 12/12/2013

Event Type  Death  

Event Description

It was reported through an identified online obituary that the patient passed away.The patient died in a hospital, but no information was provided on the cause or other circumstances of death the generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution.Follow up with the servicing funeral home showed that per their process, the device was explanted since they screen for medical devices, but no specific record was present.They also reportedly discard of explanted devices.No additional pertinent information has been received to date.

Event Description

Communication from the hospital treating the patient at her time of death showed that the primary cause of death was listed as complications of bacterial meningitis.Contributing factors were cardiac arrest and severe cerebral edema, subarachnoid hemorrhage, and intracerebral hemorrhage.No additional pertinent information has been received to date.

• 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: 6379640
• MDR Text Key: 69091497
• Report Number: 1644487-2017-03328
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2003
• Device Model Number: 101
• Device Lot Number: 5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2002
• 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: 32 YR