MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Battery Problem (2885)

Patient Problem Depression (2361)

Event Date 10/29/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had been experiencing an increase in depression, had made a couple suicide attempts, and subsequently was hospitalized.The patient¿s device was unable to be interrogated which is believed to be due to end of service.A battery life calculation using the available programming history showed approximately 0 years until eri = yes.The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description

The generator reaching end of service was determined to be the result of normal battery depletion.The depletion was an expected event as determined by blc and battery voltage measurement.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

The explanted generator was returned on (b)(6) 2015.Analysis is underway but has not been completed.

Event Description

Information was received that the patient underwent generator replacement on (b)(6) 2014.Attempts for product return were made but the explanted generator has not been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4279140
• MDR Text Key: 5029554
• Report Number: 1644487-2014-03146
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2007
• Device Model Number: 102
• Device Lot Number: 015030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2015; 04/09/2015; 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2006
• 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): Hospitalization
• Patient Age: 58 YR