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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Therapeutic Effects, Unexpected (2099); Depression (2361)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

Clinic notes were received on 09/27/2016.Notes dated (b)(6) 2016 mention that vns was decreased and patient had increase in depression.Notes state high impedance.Notes state vns settings unchanged and almost at end of generator battery.No further relevant information has been received to date.

Event Description

It was reported by the physician that the high impedance was first seen on (b)(6) 2014.It was also stated that vns helped relieve symptoms of depression and when the vns was no longer in service symptoms of depression worsened.From programming history provided from the physician, the patient's device was disabled on (b)(6) 2016.It is likely that only when the device was turned off was when the vns stopped helping the patient's depression.No further relevant information has been received to date.

Manufacturer Narrative

Supplemental mdr #1 inadvertently omitted evaluation codes that were known prior to submission of the mdr.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• 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: 6047360
• MDR Text Key: 58503999
• Report Number: 1644487-2016-02426
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2016; 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2005
• 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: 58 YR