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 Seizures (2063)

Event Date 09/01/2016

Event Type  Injury  

Event Description

It was reported that the patient was informed by her cardiologist that she did not need vns, so she stopped seeing her neurologist to manage her device.The patient's device reportedly depleted around (b)(6) 2016, and the patient had an increase in seizures.The patient went back to her neurologist and was referred for generator replacement surgery, as the neurologist believed that the vns was necessary.A battery life calculation did not support that the patient's device would have been depleted at that time.Attempts for further information were unsuccessful to date.A blc was performed, which resulted in 3.8 years until neos=yes.The last known settings were from (b)(6) 2012: 1.75ma/20hz/250us/30sec/3min.

Event Description

Updated settings were provided.An updated battery life calculation did not support that the device was depleted in (b)(6) 2016.No further relevant information has been received to date.

Event Description

The patient reported that her device had been off for years, but it was unclear if the device was programmed off or if it depleted.No further relevant information has been received to date.

Event Description

The physician stated that the patient's device had depleted normally.No surgery has occurred 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: 6600157
• MDR Text Key: 76235106
• Report Number: 1644487-2017-03898
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2011
• Device Model Number: 103
• Device Lot Number: 201130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2009
• 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): Required Intervention
• Patient Age: 64 YR