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

Model Number 102

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

Patient Problems Depression (2361); No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that the vns patient had been experiencing an increase in depression or other depressive symptoms including suicidal ideations for the past six months without any suicide attempts.Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.A battery life calculation using the available programming history showed 0 years remaining until neos = yes.Clinic notes indicate that the patient had been doing well from (b)(6) 2014.The patient was referred for surgery but no know surgical interventions have occurred to date.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Product analysis of the explanted generator concluded that the generator reached end of service due to normal battery depletion.No abnormal performance or any other type of adverse condition was found.

Event Description

Additional information was received that the patient underwent generator replacement due to battery depletion.The generator was unable to be interrogated due to end of service condition of the device.The explanted generator was returned to the manufacturer.Analysis is underway but has not been completed.

Manufacturer Narrative

Review of the available programming and diagnostic history.

• 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: 4310136
• MDR Text Key: 5134745
• Report Number: 1644487-2014-03242
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2014

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: 07/31/2007
• Device Model Number: 102
• Device Lot Number: 013755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/02/2015; 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2005
• 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): Required Intervention
• Patient Age: 59 YR