MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Insufficient Information (3190)

Patient Problems Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361)

Event Date 01/01/2014

Event Type  Injury  

Event Description

It was reported that the patient was having suicidal ideation and an increase in depression and anxiety.The patient has been referred for a generator replacement but it is unclear if that is related to the issues she is having.Surgery if likely but has not occurred to date.

Event Description

On (b)(6) 2014 the physician reported that the patient¿s increase in depression and suicidal ideation is not related to vns.The patient is chronically depressed and frequently suicidal for years.The patient was seen for follow up and the physician suggested she re-enter therapy but geography and finances preclude this.The physician stated that despite ongoing depression and suicidality, she does seem to have benefitted from vns treatment as these symptoms are less severe than before vns.No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in depression/suicidal ideation.

Event Description

It was reported that during the patient¿s generator replacement surgery on (b)(6) 2014 due to battery depletion, high impedance was observed with the new generator.A full revision was performed.Attempts for product return were made but the explanted products have not been returned for product analysis to date.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.Device manufacture date; corrected data: additional information was received which changes the product from what was initially reported.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 4210220
• MDR Text Key: 4984421
• Report Number: 1644487-2014-02873
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2014

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: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2014; 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2005
• 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): Other
• Patient Age: 45 YR