MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 08/10/2013

Event Type  Death  

Event Description

It was found through obituary that the patient passed away at a hospital, where he lived and was treated by his following neurologist.The patient's death discharge report indicated that the final cause of death was cardiopulmonary arrest secondary to possible aspiration pneumonia with not direct cause as: seizure disorder and paranoid schizophrenia.During the eight months prior to the patient's death, he became increasingly wheelchair bound and kyphoscoliotic, and was working with speech therapy for dysphagia.Two weeks prior to death, he had an episode of respiratory distress that led to intubation and icu stay; the patient chose comfort feeds as a method of treatment and developed increasing respiratory distress likely secondary to pneumonitis and aspiration that eventually led to his death.A battery life calculation found that the patient's generator was expected to have reached end of service approximately 10 months prior to the patient's death.No further relevant information has been received to date.The suspect product has not been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6404628
• MDR Text Key: 69945306
• Report Number: 1644487-2017-03381
• 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
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2007
• Device Model Number: 102
• Device Lot Number: 014818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2006
• 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: 66 YR