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

Model Number 102

Device Problem Low Battery (2584)

Patient Problem Death (1802)

Event Date 04/19/2017

Event Type  Death  

Event Description

Patient was referred for prophylactic generator replacement based on estimated battery life calculation (0 years remaining).Low battery warning was also observed per the clinic notes.Prior to generator replacement, however, the patient passed away.The family informed the surgeon's office that the patient would not be able to attend the consult as the passed away.Information was received from the patient's neurologist that the patient's response to vns therapy was seizure reduction.However, no details regarding the death was known to the neurologist.Patient has a history of 2nd generalized and complex partial seizures.Patient was compliant with medications and was on primidone, carbamazepine, lamotrigine, and few other medications.Patient was undergoing evaluation for replacement of vns due to generator failure/battery depletion.An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.

• 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: 6607900
• MDR Text Key: 76521377
• Report Number: 1644487-2017-03906
• 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
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/23/2007
• Device Model Number: 102
• Device Lot Number: 014097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2005
• 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: 57 YR