MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

Model Number 303-20

Device Problems Degraded (1153); Unexpected Therapeutic Results (1631)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 08/03/2014

Event Type  Injury  

Event Description

It was reported that the vns patient went to the er on (b)(6) 2014 due to painful stimulation in her neck which was occurring every 10 minutes for the past month.During the patient¿s last office visit in (b)(6) 2014, the device output current was increased from 2.75ma to 3.25ma.The patient¿s device was tested during the visit and diagnostic results showed normal device function.The patient underwent surgery on (b)(6) 2014 to explant her generator and lead due to electrode failure and pain.The explanting facility discarded the explanted devices; therefore, no analysis can be performed.The patient has not been re-implanted to date to allow sufficient time to let her vagus nerve heal.

Manufacturer Narrative

Manufacturer Narrative

This information was inadvertently left off of initial mfr.Report.

Event Description

Clinic notes were received for patient's referral for vns implantation.Per notes, patient requests for the vns to be re-implanted due to increased frequency of seizures.

• Brand Name: LEAD MODEL 303
• 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: 4210450
• MDR Text Key: 4966353
• Report Number: 1644487-2014-02879
• Device Sequence Number: 1
• Product Code: LYJ
• 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,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2014
• Device Model Number: 303-20
• Device Lot Number: 2859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2010
• 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: 34 YR