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

Model Number 302-20

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Seizures (2063); Therapeutic Response, Decreased (2271)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

It was reported that the patient had experienced an increase in seizures over the past two months.Interrogation and diagnostics of the vns device showed high impedance results.No known trauma was reported to have occurred.Patient is referred for a full revision of the generator and lead as a result.Clinic notes were received stating that the patient's seizures have increased.Patient was also reported to be blacking out with seizures and is no longer able to hear during the seizures.No known surgical interventions have occurred to date.

Event Description

The patient underwent full revision surgery on (b)(6) 2015.Attempts were made for the return of the explanted lead and generator but only the generator was received on (b)(6) 2015.Analysis is underway but has not been completed.

Event Description

Analysis was completed on the returned generator and the generator performed according to functional specifications.During the product analysis, there were no anomalies found with the pulse generator.

• 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: 5111738
• MDR Text Key: 27185704
• Report Number: 1644487-2015-05962
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: 302-20
• Device Lot Number: 200485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2007
• 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: 31 YR