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

Model Number 302-20

Device Problem Fracture (1260)

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

Event Date 01/31/2018

Event Type  malfunction  

Event Description

Report received that a patient was seen in the clinic and reported experiencing a lack of perception of vns stimulation, an increase in depression symptoms, and a deepening of her voice during stimulation.The vns was interrogated and high impedance was observed.The clinic notes from this visit were also reviewed and indicated that the patient had a worsening of depression symptoms especially over the few weeks prior to this appointment.The patient's husband was reportedly concerned that the vns was not working properly.No surgical intervention has occurred to date.No additional relevant information has been obtained.

Event Description

Further information was received that the patient's vns lead and generator were replaced.The explanting hospital reportedly discards products after explant so the devices were not returned to the manufacturer.No additional relevant information has been received to date.

• 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: 7341801
• MDR Text Key: 102525499
• Report Number: 1644487-2018-00374
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2008
• Device Model Number: 302-20
• Device Lot Number: 1334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2005
• 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: 64 YR